SMART CORRECTION EXTERNAL FIXATOR SYSTEM

SMART CORRECTION®

EXTERNAL FIXATOR SYSTEMSURGICAL TECHNIQUE

© 2021 WishBone Medical, Inc.

Introduction

Indications & Contraindications .................................................................................................................................................... 4

System Components ..................................................................................................................................................................... 5-8

Case Examples ................................................................................................................................................................................. 9-13

Surgical Technique

Long Bone ...................................................................................................................................................................................... 14-28

X-Ray Imaging ...................................................................................................................................................................................... 29

Software .......................................................................................................................................................................................... 30-56

Foot Frame ..................................................................................................................................................................................... 57-67

Strut Exchange............................................................................................................................................................................ 68-70

Hardware Removal ..................................................................................................................................................................... 71-72

Case Layouts

......................................................................................................... 73-75

TABLE OF CONTENTSTABLE OF CONTENTS

SMART CORRECTION | SURGICAL TECHNIQUE 3

Smart Correction®

EXTERNAL FIXATOR SYSTEMIntroduction

1. Eren, Ilker & Eralp, Levent & Kocaoğlu, Mehmet. (2013). Comparative clinical study on deformity correction accuracy of different external fixators. International orthopaedics. 37. 10.1007/s00264-013-2116-x.

The WishBone Medical Smart Correction® System is intended for use in pediatric subgroups (except newborns)

and adult patients for the treatment of open and closed fractures, arthrodesis and pseudoarthrosis of long bones,

limb lengthening, deformity and angular correction, bony or soft tissue defect correction and malunions.

Smart Correction consists of hexapod fixator elements, surgical instruments, and a copyrighted web-based software

application for deformity correction and fracture reduction.

Eren, et al in the Journal of International Orthopaedics (SICOT)1 reported, “The SC fixator demonstrates higher

deformity correction accuracy than an Ilizarov external fixator.” Smart Correction offers a wide variety of wire and pin

fixation choices as well as the lowest profile ring offered at 6mm. The technology creates a strong but lightweight

frame for enhanced patient comfort.

The system provides easy assembly, mechanical stability and precise correction in all planes via web-based software

www.Click2Correct.com.


TABLE OF CONTENTSINTENDED USE

INDICATIONS

The Smart Correction® System is indicated for the following:

• Joint contracture resulting in loss of range of motion

• Fractures and disease which generally may result in joint contractures or loss of range of motion

• Fractures requiring distraction

• Open and closed fracture fixation, including fractures of long bones (intracapsular, intertrochanteric, supracondylar, condylar)

• Correction of bony or soft tissue defects

• Correction of bony or soft tissue deformities

• Joint arthrodesis

• Infected fractures or nonunions

• Limb lengthening by epiphyseal or metaphyseal distraction

• Pseudoarthrosis of long bones

CONTRAINDICATIONS

• Patients who are unwilling or incapable of following postoperative care instructions or materials. Express Strut prescription is to be made at the surgeon’s discretion. Patients that may attempt unauthorized adjustments and patients with mental, physical, or neurological conditions which may impair the ability to cooperate with the postoperative regimen may not be suitable for use of these devices.

• Not intended for spine applications.

For product information, including indications, contraindications, warnings, precautions and potential adverse effects, as well as Patient Instructions for Use, visit WishBone Medical’s Instructions for Use page online: www.WishBoneMedical.com/IFU.

Software is not validated for use with foot frames at this time.


TABLE OF CONTENTSCOMPONENTS

Strut Type Range (mm)

Dual Joint Standard Strut, XX Short 60 75

Dual Joint Standard Strut, X Short 75 95

Dual Joint Standard Strut, Short 90 125

Dual Joint Standard Strut, Medium 115 175

Dual Joint Standard Strut, Long 165 275

Dual Joint Express Strut, XX Short 80 95

Dual Joint Express Strut, X Short 100 120

Dual Joint Express Strut, Short 115 150

Dual Joint Express Strut, Medium 140 200

Dual Joint Express Strut, Long 190 300

Warning: Express Strut prescription is to be made at

the surgeon's discretion. Patients that may attempt

unauthorized adjustments and patients with mental,

physical, or neurological conditions which may impair the

ability to cooperate with the postoperative regimen may not

be suitable for use of these devices.

Rings• Low-profile aluminum (6mm full rings, 8mm partial rings)

• Concentric dual holes allow optimal wire and half pin positioning

• Modular: Full Ring, 2/3 Ring, 1/3 Ring, Foot Ring available with inner diameters between 105mm and 240mm in 15mm size increments

• Modular ring constructs can be connected via 1/3 and 2/3 Rings of the same diameter, using the 1/3-2/3 Ring Connector, 20mm Connection Bolts, and Standard Nuts. The partial rings may be removed during the correction lifespan to increase flexion as your patient heals

Free strut positioning allows surgeons to mount struts wherever needed on a ring; neither a mounting parameter, master tab nor a reference ring is required.

The Smart Correction® System Delivered Goods Form (LIT-DGF-SCEF) is available for ordering information.

Access the document online at www.WishBoneMedical.com/product/SC.


Half Pins• Available in self-drilling and blunt half pins with AO

Connection and a variety of thread lengths

• Sizes in 4.5mm, 5.0mm and 6.0mm diameters

• Universal 6mm shank design for attachment to clamps

WiresSmart Correction offers both straight and olive stainless steel

wires in 1.6mm and 2.0mm diameters with bayonet tips.


Threaded RodsThreaded rods are used to provide additional structural stability to ring constructs.

They attach from one ring directly to another. The threaded rods are made from

stainless steel (316 LVM) in 60-300mm lengths.

Dual rod connectors are available in Short (20mm), Medium (40mm), and Long

(60mm) sizes. They may be used to assemble two threaded rods together that create

a total length of 300mm or less.

Wire and Half Pin ClampsSmart Correction offers Standard and Advanced Clamps, as well as cubes, for half pin fixation. Standard Wire Clamps are available for wire fixation.

Advanced Pin Clamps allow for more flexible positioning (height and biplanar angulation)

* Washers (Standard, Locking) are available for use at connection sites.

* Standard Nut and Long Nut are available for connection of clamps and threaded rods to ring.

Connection bolts are available for connection of cubes to rings.

Cubes for securing half pins above or below the ring

Standard Wire Clamp

Standard Pin Clamp



Instrumentation

Single Hand Wire Tensioner

Fork Tensioner HeadTensioner Head

Drill Sleeve Handle

Drill Sleeve Guide - Long

Drill Sleeve Guide - Short

Trocar - Long

Trocar - Short

Short Drill Sleeve Guide: For half pins of 120mm and 150mm total length in all avail-able thread lengths

Long Drill Sleeve Guide: For half pins of 180mm total length and larger in all available thread lengths

10mm Hex Bolt Ratchet Wrench

Slotted Wrench

13mm Hex Bolt Wrench

10mm Hex Bolt Wrench

10mm Socket Wrench

Wire Cutter/Plier

13mm Hex Bolt: For tightening of Pin Clamps and Cubes

10mm Hex Wrenches For tightening of all 10mm hexes

8Nm Torque Limiting Ratchet Wrench 10mm Hex Bolt Socket For tightening Shoulder Bolts to struts only



Instrumentation (cont.)

USER-FRIENDLY SOFTWARE

Click2Correct™ Preoperative Planning and Templating Software offers

an intuitive user interface and improved measuring template library

through surgeon collaborations.* The web-based software is available

on most common platforms via www.Click2Correct.com.

Rod Cutter

(To be sterilized separately)

T-Handle with Jacobs Chuck

T-Handle for Half Pins (AO Connector)

AO Drill Bit 3.2 x 200mm (for 4.5 & 5.0mm Half Pins)

AO Drill Bit 4.8 x 200mm (for 6.0mm Half Pins)

Depth Gauge, 60mm

T-Allen Wrench: For tightening of set screw for cube assembly with half pin

T-Allen Wrench, 3mm/150mm

*Software is not validated for use with foot frames at this time.

CASE STUDIES


Smart Correction®

Computer Assisted Circular Hexapod Fixator Case Examples

10 YO, M, 3 years ago Falling from high, Procurvatum + Varus Deformity + 4cm LLD

15 YO, F, Multiple Hereditary Exostoses, Genu Varum + 4 cm LLD

17 YO, M, Operated Tibia Nonunion, Varus+Procurvatum

7

Smart Correction®





7

10 YO. Impact Injury, Procurvatum + Varus Deformity + 4cm LLD

Pre-Op

Surgical Intra-Op

Smart Correction®





7

Smart Correction®





7

Post-Op

CASE STUDIES


Smart Correction®





7

17 YO. M, Operated Tibia Nonunion,Varus + Procurvatum

Pre-Op

Surgical Intra-Op

Post-Op

Smart Correction®





7

Smart Correction®





7

Smart Correction®





7

Smart Correction®





7

CASE STUDIES


X YO. M, Acute Compression

Pre-Op

Post-Op

Smart Correction®



17 YO, F, Bilateral Genu Varum

14 YO, F, Multiple LE Deformities

Smart Correction®





Smart Correction®





Smart Correction®





Smart Correction®





Smart Correction®





Smart Correction®





CASE STUDIES


17 YO. F, Bilateral Genu Varum

Pre-Op Surgical Intra-Op

Post-Op

Smart Correction®





Smart Correction®





Smart Correction®





Smart Correction®





Smart Correction®





CASE STUDIES


Smart Correction®





Smart Correction®





Smart Correction®





14 YO. F, Multiple Deformities

Pre-Op Surgical Intra-Op

Post-Op

Smart Correction®





Smart Correction®





Smart Correction®





SURGICAL TECHNIQUELONG BONE


During preoperative planning, the proximal ring should be at least 5mm proximal to the fracture or osteotomy site.

Position the ring such that the fixation hole marked with #1 is placed as approximately anterior to the proximal segment of bone as possible in the sagittal plane (fig. 2).

The ring is placed perpendicular (at 90°) to the long axis of the bone. All rings should be placed such that the numbers are oriented right side up when viewed from the distal aspect (fig. 3).

Proximal Ring Positioning

fig. 1

1

Ring diameter needs to allow at least 2cm (two fingers) of distance between the skin and the ring circumferentially (fig. 1).

Ring Selection

With a design that enables efficient, precise calculations with unrestricted strut placement, Smart Correction allows surgeons to customize the frame to meet each patient’s needs.

Preparation

fig. 2

fig. 3

TABLE OF CONTENTSSURGICAL TECHNIQUELONG BONE

TABLE OF CONTENTSSURGICAL TECHNIQUELONG BONE (CONT.)


Wires are offered in standard and olive configurations in two different diameters: 1.6mm and 2.0mm.

Consider patient anatomy prior to selecting wire size and type.

Warning: Particular care should be taken that wires and half pins do not enter the joints or damage the growth plates in children.

Note: If using an olive wire, wire stopper washers are available for use. Insert the washer onto the sharp end of the olive wire prior to wire insertion.

Wire Selection2 Wire Placement Location3

Insert the wire under power perpendicular to the long axis of the bone (fig. 4). Wait until the wire is in contact with the bone before drilling. As soon as the tip of the wire penetrates the far cortex, stop the drill.

Once the wire exits the bone, drill or tap the wire through the remaining soft tissue. Be careful of soft tissues when advancing the wire. Once the wire is placed, the sharp tip should be cut off to prevent injury while ensuring that a sufficient length remains for tensioning (fig. 5).

Wire Insertion4

fig. 4

fig. 5

Consideration of neurovascular structures (safe zones) must be made when inserting half pins and wires.

Caution: Ensure sufficient fixation internal/external to the frame. It is recommended to insert a minimum of three points of fixation per circular ring and a minimum of four points of fixation per foot ring.



Position the proximal ring such that the fixation hole marked with #1 is placed approximately anterior. Select the location for placement of the first wire connector.

Proximal Ring Placement

fig. 6

5

While using the end of a 10mm Hex Bolt Wrench to maintain position of the clamp, use another 10mm wrench to tighten the nut (fig. 8). Fully tighten the nut opposite of where the tensioner will be applied.

Tightening Standard Wire Clamps7

Using the Standard Wire Clamp (fig. 6), connect the wire to the ring (fig. 7).

Note: Both inner and outer holes can be used for wires and half pins. For instances where two wire clamps may be used in holes beside each other, consider placing one clamp on the inner hole and one clamp on the outer hole to allow for more space for tensioning.

Wire Connection6

fig. 7A fig. 7B

fig. 8



Select desired wire tensioner head (Fork Tensioner Head or Tensioner Head) and attach it to the tensioner body by pressing it into the boss (fig. 9). Position tensioner over the wire from the tensioning side of the ring. Ensure tensioner head is in contact with the clamp or ring before tensioning (fig. 10).

The wire tensioner contains markings to indicate amount of tension from 0-125kg (fig. 11). Wires are recommended to be tensioned between 70-125kg.

Caution: If using an olive wire, consider the intended use of the wire within the correction and if a wire stopper washer was used prior to tensioning. Etched lines are present on the wire to indicate which side of the bone the olive is on.

Tensioning8

Tighten the nut to secure the wire clamp on the tensioned side of the ring (fig. 12).

Tighten Wire Bolt and Nut9

fig. 9

fig. 10

Using the Wire Cutter/Plier, cut the end of the wire leaving enough length to allow for additional tensioning on at least one side if needed (fig. 13).

Wire covers are available for patient comfort.

Wire Trimming10

fig. 13

fig. 11

fig. 12

f



Select appropriate size and type of half pin. Half pins are offered in self-drilling and self-tapping configurations in 4.5mm, 5.0mm, and 6.0mm thread diameters and 20mm, 30mm, 40mm, and 50mm thread lengths.

Consider patient anatomy prior to selecting half pin size and type. Washers (Standard, Locking) are available for use at connection sites.

Warning: Two locking washers should not be used at the same interface. However, a locking washer and standard washer or two standard washers may be used together. Advanced Pin Clamp Assembly

Advanced Pin Clamps can be attached to inner or outer ring holes using either standard or Long Nuts. However, most stable fixation is achieved with clamp placement oriented to the inside of the ring (fig. 14).

To achieve optimal fixation of bone fragments, pin angle should be no greater than 30° relative to the ring.

Caution: Washers should only be used between the bottom side of the ring and the nut that is securing the clamp.

Standard Pin Clamp AssemblyStandard Pin Clamps can be attached to inner or outer ring holes using either standard or Long Nuts (fig. 15). Cube Assembly

Cubes can be assembled to the ring via gold bolts (fig. 16A). If washers are used, longer bolt length may be required.

Insert pin sleeve through the cube, ensuring the line on the pin sleeve is aligned to the threaded holes on the cube (fig. 16B).

Once half pin is inserted into the bone through the cube, insert the set screw through threaded holes of the cube and tighten using the T-Allen Wrench to lock the half pin in place (fig. 16B).

Caution: Washers should only be used between the bottom side of the ring and the nut that is securing the cube. No more than two washers should be used at a single connection site.

Note: If washers are used with the cube, the 16mm connection bolt should be used. However, the cube hole closest to the ring should not be used for half pin connection.

Half Pin Insertion11A

fig. 14

fig. 15

fig. 16A

fig. 16B



Drill bits are available for predrilling for half pins. Drill Sleeve Guides and Trocars are available to aid with drilling and half pin insertion.

Thread the drill sleeve guide into the drill sleeve handle. From there, it can be used with half pins, drill bits, and trocars. There are long and short trocars for use with the long and short drill sleeve guides (fig. 17).

• Half pins (120mm-150mm): Use Short Drill Sleeve Guide/Trocar

• Drill bits & half pins (180mm & up): Use Long Drill Sleeve Guide/Trocar

• To aid in the alignment of the drill bit, half pin, and connector placement, the trocar can be placed directly through the connector to mark location for drilling (fig. 18). Following this, the connector can be moved out of the way so that the drill bit or half pin may be used through drill sleeve guide. When drilling or inserting half pins, the component should be inserted until bicortical bone purchase is achieved.

A depth gauge is available to aid selection of the appropriate half pin.

After predrilling, the depth gauge should be used such that the depth gauge body comes into contact with the bone and the depth gauge wire can be placed through the predrilled hole (19A). The hook at the end of the wire can grab onto the far cortex. The measurement indicated by the depth gauge reflects the appropriate half pin thread length (fig. 19B).

In the occurrence that the measurement does not correspond to a half pin thread length, the next largest half pin thread length should be chosen to ensure full thread engagement and that bicortical bone purchase is achieved.

Use power or a T-Handle to insert half pin. Tighten clamp to half pin.

Note: Pre-drilling is required for self tapping half pins. Pre-drilling for self-drilling half pins is recommended for hard, dense cortical bone.

Note: 3.2mm Drill Bit must be used for 4.5 & 5.0mm half pins; 4.8mm Drill Bit must be used for 6.0mm half pins.

Predrilling for Half Pins (Optional)

fig. 17

fig. 18

fig. 19A

11B

fig. 19B



Following the same method described in Step 11, insert a second half pin divergent to the first half pin (fig. 20).

2nd Half Pin12

fig. 20

Standard and Advanced Clamps can be attached to the ring using Standard or Long Nuts.

Cubes may also be used to attach additional half pins to rings. Attach cube to the ring using a connection bolt. Insert pin sleeve into the the hole where the half pin is to be inserted. Insert the half pin into the bone. Once desired position is achieved, secure the half pin to the cube using the 6mm set screw and a T-Allen Wrench.

Insert additional half pins or wires being careful to avoid planned location of struts.

Note: Ensure that the groove on the washer on the Standard Wire Clamp is aligned with the wire.

Trim excess length of wires and/or half pins using the Wire Cutter/Plier or Rod Cutter (fig. 21).

Half pin and wire covers are available for patient comfort.

Remaining Half Pin(s) / Wire(s)13

fig. 21



Insert the wire as outlined in Steps 4-10.

Insert Wire(s)

Align the Distal Ring

Perform Half Pin Insertion

Double Check Tightness of All Connectors

Place the Distal Ring14

15

16

17

18

14

fig. 23

Insert the half pin(s) as outlined in Steps 11-13.

All connections must be fully tightened using the 10mm Hex Bolt Wrench prior to strut placement (fig. 23).

Caution: Torque Limiting Ratchet Wrench is intended to be used to tighten Shoulder Bolts to struts. Use with other connector elements may not provide sufficient torque.

Ring diameter needs to allow at least 2cm (two fingers) of distance between the skin and the ring circumferentially.

The distal ring shall be aligned approximately parallel to the proximal ring.

Position the distal ring such that the fixation hole marked with #1 is placed approximately anterior (fig. 22).

fig. 22



Select the Appropriate Strut

Fix Struts to Ring

Both Express Struts (for rapid adjustment) and Standard Struts are available.

Warning: Express Strut use is to be made at the surgeon’s discretion. Patients that may attempt unauthorized adjustments and patients with mental, physical, or neurological conditions which may impair the ability to cooperate with the postoperative regimen may not be suitable for use of these devices.

Note: Size selection should be made with consideration of strut exchange (fig. 24).

The struts must be installed and fixed to the outer ring holes for software compatibility, in a rough triangular geometric configuration. The struts should be placed in pairs approximately equidistant around the circumference of the ring and secured to the ring using Shoulder Bolts (fig. 25).

Tighten Shoulder Bolts using two 10mm wrenches (fig. 26).

Note: It is recommended to tighten the Shoulder Bolts to 8Nm of torque. An 8Nm Torque Limiting Ratchet Wrench is available for Shoulder Bolt tightening.

The modular nature of Smart Correction allows surgeons to choose the final position of the struts, even allowing the struts in a particular pair to be separated by a number of holes for easy access to potential wound sites or skin flaps.

Note: Different diameter rings can be used in the same frame as needed. Full rings may also be combined with 2/3 rings or foot rings.

Note: A surgeon must use the recommended six struts if utilizing the Smart Correction Software.

Warning: Washers cannot be used at strut attachment sites.

19

20

fig. 24

fig. 25

fig. 26



Strut PositioningIdeal strut positions are shown in the tables below.

Note: Use Shoulder Bolts, 6mm (silver) on full rings. Use Shoulder Bolts, 8mm (purple) on partial rings.

Proximal Ring Size S1 & S2 S3 & S4 S5 & S6 Acceptable

Tolerance

105 mm 1 & 2 10 & 11 19 & 20 ± 2 holes

120 mm 1 & 2 11 & 12 21 & 22 ± 2 holes

135 mm 1 & 2 12 & 13 23 & 24 ± 2 holes

150 mm 1 & 2 13 & 14 25 & 26 ± 2 holes

165 mm 1 & 2 14 & 15 27 & 28 ± 3 holes

180 mm 1 & 2 15 & 16 29 & 30 ± 3 holes

195 mm 1 & 2 16 & 17 31 & 32 ± 4 holes

210 mm 1 & 2 17 & 18 33 & 34 ± 4 holes

225 mm 1 & 2 18 & 19 35 & 36 ± 4 holes

240 mm 1 & 2 19 & 20 38 & 39 ± 4 holes

Distal Ring Size S2 & S3 S4 & S5 S6 & S1 Acceptable

Tolerance

105 mm 25 & 6 7 & 15 16 & 24 ± 2 holes

120 mm 6 & 7 16 & 17 26 & 27 ± 2 holes

135 mm 6 & 7 17 & 18 28 & 29 ± 2 holes

150 mm 7 & 8 19 & 20 31 & 32 ± 2 holes

165 mm 7 & 8 20 & 21 32 & 33 ± 3 holes

180 mm 8 & 9 22 & 23 36 & 37 ± 3 holes

195 mm 9 & 10 24 & 25 39 & 40 ± 4 holes

210 mm 9 & 10 25 & 26 41 & 42 ± 4 holes

225 mm 10 & 11 27 & 28 44 & 45 ± 4 holes

240 mm 8 & 9 25 & 26 43 & 44 ± 4 holes

21

fig. 23

fig. 24

Proximal

(120mm shown)

Distal

(120mm shown)



Proximal 2/3 Ring Size S1 & S2 S3 & S4 S5 & S6

105mm 13 & 14 21 & 22 6 & 7

120mm 15 & 16 24 & 25 7 & 8

135mm 16 & 17 26 & 27 7 & 8

150mm 19 & 20 29 & 30 8 & 9

165mm 20 & 21 31 & 32 8 & 9

180mm 21 & 22 34 & 35 9 & 10

195mm 23 & 24 37 & 38 10 & 11

210mm 24 & 25 39 & 40 10 & 11

225mm 27 & 28 42 & 43 11 & 12

240mm 27 & 28 44 & 45 11 & 12

Posterior Open

Distal 2/3 Ring Size S2 & S3 S4 & S5 S6 & S1

105mm 6 & 7 13 & 14 21 & 22

120mm 7 & 8 15 & 16 24 & 25

135mm 7 & 8 16 & 17 26 & 27

150mm 8 & 9 19 & 20 29 & 30

165mm 8 & 9 20 & 21 31 & 32

180mm 9 & 10 21 & 22 34 & 35

195mm 10 & 11 23 & 24 37 & 38

210mm 10 & 11 24 & 25 39 & 40

225mm 11 & 12 27 & 28 42 & 43

240mm 11 & 12 27 & 28 44 & 45

Foot Ring Size S1 & S2 S3 & S4 S5 & S6

S - 105mm 9 & 20 19 & 14 13 & 8

M - 120mm 10 & 23 22 & 17 16 & 9

L - 135mm 11 & 26 25 & 19 18 & 10

Anterior Open



Thread Appropriate Bolts

Adjust Strut to Distal Ring

Use Wrenches to Tighten Strut

Align the strut with the intended ring hole. Position the strut so that length indicator is visible (fig. 27).

Align Strut22

23

24

25

Thread the appropriate size Shoulder Bolt into the strut through the outer hole in the ring (fig. 28).

• 6mm Shoulder Bolts (silver) are to be used with full rings (6mm thickness) (fig. 29A).

• 8mm Shoulder Bolts (purple) are to be used with 1/3, 2/3 and foot rings (8mm thickness) (fig. 29B).

fig. 28

fig. 30

Repeat Steps 19-23 for each strut.

Use two 10mm wrenches to tighten the Shoulder Bolts (fig. 30).


fig. 29A

fig. 27

fig. 29B



Warning: Express Strut use is to be made at the surgeon's discretion. Patients that may attempt unauthorized adjustments and patients with mental, physical, or neurological conditions which may impair the ability to cooperate with the postoperative regimen may not be suitable for use of these devices.

Note: The Express Strut locking collar is designated by straight knurls.

Re-Tighten Each Bolt and Nut

If using an Express Strut, tighten strut locking collar counterclockwise until strut height is fixed in place such that no gross adjustments can be made (fig. 31).

Tighten Locking Collar26

27

fig. 32

28 Attach Strut ID Clips

fig. 33B

Ensure that Strut ID Clips are attached to the correct struts in order (the most anterior strut as 1). To prevent unintentional disassembly, Standard Struts and XXS Express Struts must have ID clips attached at the top of the strut (fig. 33A).

Strut length and position must be recorded and entered accurately into Click2Correct Software to ensure that desired prescription for correction schedule can be calculated and obtained.

Strut ID clip numbers should be in ascending order in the same orientation as proximal ring hole numbers (fig. 33B).

Verify that the colors/numbers and orientation of the ID clips are correct prior to using Smart Correction software.

All nuts and bolts should be fully tightened with the 10mm Hex Bolt Wrench. The 13mm Hex Bolt Wrench is available for counter-torque on cubes and pin clamps (fig. 32).

8Nm Torque Limiting Ratchet Wrench is available for final tightening of Shoulder Bolts.


fig. 31

fig. 33A

Express Strut

Standard Strut



29 Consider Mounting a 2nd Level of Fixation to Increase Stability

30

A full ring can be built above a previously affixed ring using a 2/3 and 1/3 ring of the same size with the 1/3-2/3 ring connector, 20mm (green) connection bolts (x2) and nuts (x2) (fig. 34).

Partial rings may be attached to the frame using struts or threaded rods in approximate equidistant position (fig. 35).

Nuts are available to be placed on either side of the ring-threaded rod attachment site.

Dual Rod Connectors (Optional)

If desired threaded rod length is unavailable, dual rod connectors may be used to connect two threaded rods together to create an overall length up to 300mm.

The threaded rods should be fully threaded into the connector such that the ends of the threaded rods are touching at the approximate center of the dual rod connector. Nuts are available to be placed on either side of the dual rod connector to assist with locking in place the position of the dual rod connector.

Patient Safety & ComfortPin and wire covers are available to place at the end of cut half pin and wires.

Sponges and sponge clips are available for use at anchorage insertion sites to aid with pin site maintenance (fig. 36). Sponges can be placed on the insertion site with sponge clips available to attach to the anchorage element to hold the sponge in place.

fig. 34

fig. 36

fig. 35


Position the X-ray source over the center of the frame between the two rings.

X-Ray Positioning

It is important that the entire frame can be seen on the X-ray.

650mm-1500mm distance (A)

Record the number that appears closest to the X-ray source on both the proximal and distal ring at the time the X-ray is taken (F & G).

The Smart Correction® Frame Information Form (LIT-FIF-SCEF) is available for frame configuration and X-ray

measurement documentation. Access the document online at www.WishBoneMedical.com/product/SC.

Record the number that appears closest to the X-ray source on both the proximal and distal ring at the time the X-ray is taken (B & C).

Anterior X-Ray Measurements Lateral X-Ray Measurements1 3

Record the distance between the rings and X-ray cassette (D & E).

2 Record the distance between the rings and X-ray cassette (H & I).

4

SURGICAL TECHNIQUEX-RAY IMAGING

SOFTWARE USER GUIDE


The Smart Correction® System is a copyrighted software-based, deformity correction tool. This external fixator, with its 6-strut construct, provides easy application, mechanical stability and precise deformity correction via weblinked copyrighted software.

The software facilitates deformity correction in all anatomic planes* (axial, frontal, coronal, translation).

Introduction

In order to accommodate a large quantity of information, detailed graphical images and proper sequencing of correction methods, each screen of the Smart Correction® Web Application is designed to provide an efficient user interface. To ensure the best possible experience with this site, we recommend the following display and browser settings.

Display Settings

Screen resolution of 1024 x 768 or higher.

Supported Browsers

Any HTML 5 compatible web browser.(Microsoft Edge, Microsoft Internet Explorer, Mozilla Firefox, Google Chrome and Apple Safari)

Browser Settings

Must support 128-bit SSL encryption. JavaScript enabled. Cookies enabled.

Internet Connection

A high-speed connection is recommended.

Computer System Requirements

Note: In order to use the Smart Correction Software, admin approval must be granted. It is recommended to submit an application prior to the time that software is needed.

SOFTWARE USER GUIDE


TABLE OF CONTENTSSOFTWARE USER GUIDE (CONT.)


Approved users can access the Smart Correction software using any computer or mobile device connected to the Internet from anywhere in the world. Simply visit www.Click2Correct.com to get started.

Account Registration

To register a new account,

select the Register button

in the top-right corner.

If a registered user previously opted to ‘remember me’ on their browser, a Go to Application button will display; when selected, users can return to the Click2CorrectTM Login Page.

Note: All aspects of Click2CorrectTM and Smart Correction software are handled electronically, from account registration to resetting passwords. All requests are accessed via the login page at www.Click2Correct.com.



Complete the fields shown below. Please carefully review your information prior to submitting.

Account Registration (cont.)

After verifying user information, select

Register to complete registration.

Warning: In order to protect patient

information, do not share your username

or password information with others.

Verify Email

Upon registration, you will immediately receive a confirmation email from the system ([email protected]). Please verify your email address through the link provided in the email.

Note: If the confirmation email does not

show in your inbox, check the spam folder.

Alert will no longer appear once

email is verified.



Once the account is registered, a profile link is created through the username.

User Profile

To change/update account information, click

on your name, then from the drop-down

menu, select Profile.

Upon logging in, you will be presented with a main dashboard displaying all of the current modules:

Patients | Cases | Images | SC® | Documents

Click2CorrectTM Dashboard

Note: For account issues, customer support contact information is located under the Documents page which can be accessed via the purple ‘i’ button.



To request full access to the Smart Correction software, select the orange SC® button to begin the application.

Smart Correction Authorization

Fill out the application and submit for review.

An administrator will review the application.

Once approved for full access, you will be notified via the email previously provided.

Once the application is approved, you will see a Smart Correction tab on the home page.

Application Approval



All parameters should be entered with both a magnitude and a direction. Where distance measurements are required, those numbers should be entered in millimeters, not centimeters.

The software will provide a prescription to correct the exact deformity you describe. Therefore, it is important to enter your data as accurately as possible.

You can advance from field to field within a page by using the tab key.

Advance from one page to the next by clicking on the sub tab in sequence or by clicking Next.

Data Entry Guidelines

To start a patient, click on the Patients tab.

Then, select the New button to proceed recording patient details.

Patient Tab

After clicking the New button or the Click here to add a new patient link (for the first patient record), the following form will appear.

Note: First Name, Last Name and Gender are

mandatory fields and must be entered to move

to the next step. After the information is entered,

the software will activate the Save button.



After clicking the Add Case button or the Click here to add a new case link (for new case record), the following form will appear:

Add Case

Once the mandatory fields (Subject and Hospital/Company) are filled in and saved, add pictures.

The Smart Correction calculation will then be available.

After the case is saved, X-ray images should

be stored for preoperative planning and/or

Smart Correction calculation through the link.

The Smart Correction calculation will start

through the link.

Compatible file formats: JPEG, PNG or DICOM



Add X-rays first: Fill the data fields and upload the X-ray image for preoperative planning and/or Smart Correction® calculation.

Scenario #1

Note: X-ray images should be

uploaded through the link.

Compatible file formats: JPEG, PNG or DICOM

To take measurements or excecute any preoperative planning works on the X-ray image, click on the image directly to open the preoperative planning interface.



Scenario #2

Start Calculation

Click on the Smart Correction tab to

start correction calculation.

Title is to identify the case.

Extremity side must be selected to

correctly apply internal/external

rotation.

Surgery date will be part of the

prescription date.



Select the appropriate proximal and distal ring sizes by clicking the down arrow on the drop down box. After each ring is selected, recommended strut fixation hole numbers appear in a drop-down box for each strut number. Smart Correction frame assembly flexibility allows for fixation hole numbers to be reviewed and corrected as necessary.

Frame Parameters

Proximal Ring Size S1 & S2 S3 & S4 S5 & S6 Acceptable

Tolerance

105 mm 1 & 2 10 & 11 19 & 20 ± 2 holes

120 mm 1 & 2 11 & 12 21 & 22 ± 2 holes

135 mm 1 & 2 12 & 13 23 & 24 ± 2 holes

150 mm 1 & 2 13 & 14 25 & 26 ± 2 holes

165 mm 1 & 2 14 & 15 27 & 28 ± 3 holes

180 mm 1 & 2 15 & 16 29 & 30 ± 3 holes

195 mm 1 & 2 16 & 17 31 & 32 ± 4 holes

210 mm 1 & 2 17 & 18 33 & 34 ± 4 holes

225 mm 1 & 2 18 & 19 35 & 36 ± 4 holes

240 mm 1 & 2 19 & 20 38 & 39 ± 4 holes

Distal Ring Size S2 & S3 S4 & S5 S6 & S1 Acceptable

Tolerance

105 mm 25 & 6 7 & 15 16 & 24 ± 2 holes

120 mm 6 & 7 16 & 17 26 & 27 ± 2 holes

135 mm 6 & 7 17 & 18 28 & 29 ± 2 holes

150 mm 7 & 8 19 & 20 31 & 32 ± 2 holes

165 mm 7 & 8 20 & 21 32 & 33 ± 3 holes

180 mm 8 & 9 22 & 23 36 & 37 ± 3 holes

195 mm 9 & 10 24 & 25 39 & 40 ± 4 holes

210 mm 9 & 10 25 & 26 41 & 42 ± 4 holes

225 mm 10 & 11 27 & 28 44 & 45 ± 4 holes

240 mm 8 & 9 25 & 26 43 & 44 ± 4 holes

Proximal

(120mm shown)

Distal

(120mm shown)

Next, select the appropriate strut type.

Each frame uses six struts. You can use any combination of sizes and strut family (Express or Standard) and any combination of ring type and sizes on a frame.



After all the components (rings and struts) are selected and all the fixation holes are entered, the Save button should be clicked. The software will generate AP and lateral views of the fixator model for visual confirmation.

Proximal 2/3 Ring Size S1 & S2 S3 & S4 S5 & S6

105mm 13 & 14 21 & 22 6 & 7

120mm 15 & 16 24 & 25 7 & 8

135mm 16 & 17 26 & 27 7 & 8

150mm 19 & 20 29 & 30 8 & 9

165mm 20 & 21 31 & 32 8 & 9

180mm 21 & 22 34 & 35 9 & 10

195mm 23 & 24 37 & 38 10 & 11

210mm 24 & 25 39 & 40 10 & 11

225mm 27 & 28 42 & 43 11 & 12

240mm 27 & 28 44 & 45 11 & 12

Posterior Open

Distal 2/3 Ring Size S2 & S3 S4 & S5 S6 & S1

105mm 6 & 7 13 & 14 21 & 22

120mm 7 & 8 15 & 16 24 & 25

135mm 7 & 8 16 & 17 26 & 27

150mm 8 & 9 19 & 20 29 & 30

165mm 8 & 9 20 & 21 31 & 32

180mm 9 & 10 21 & 22 34 & 35

195mm 10 & 11 23 & 24 37 & 38

210mm 10 & 11 24 & 25 39 & 40

225mm 11 & 12 27 & 28 42 & 43

240mm 11 & 12 27 & 28 44 & 45

Anterior Open



After the frame views are visually confirmed, the ‘Next’ button should be clicked. After the frame views are visually confirmed, the Next button should be clicked.



Position the X-ray source over the center of the frame between the two rings.

X-Ray Positioning

It is important that the entire frame can be seen on the X-ray.

650mm-1500mm distance (A)

Record the number that appears closest to the X-ray source on both the proximal and distal ring at the time the X-ray is taken (F & G).

The Smart Correction® Frame Information Form (LIT-FIF-SCEF) is available for frame configuration and X-ray

measurement documentation. Access the document online at www.WishBoneMedical.com/product/SC.

Record the number that appears closest to the X-ray source on both the proximal and distal ring at the time the X-ray is taken (B & C).

Anterior X-Ray Measurements Lateral X-Ray Measurements1 3

Record the distance between the rings and X-ray cassette (D & E).

2 Record the distance between the rings and X-ray cassette (H & I).

4



3 seconds after changing any of the field, the software calculates the template automatically. After the template is correctly built an X-ray image should be selected or uploaded.

Three seconds after changing any of the field, the software calculates the template automatically.

After the template is correctly built, an X-ray image should be selected or uploaded.

3 seconds after changing any of the field, the software calculates the template automatically. After the template is correctly built an X-ray image should be selected or uploaded.

The surgeon should ensure that both rings are in contact with the film cartridge, and that the X-ray target point is the midline joining the two nearest points of the rings. If there is space between any of the rings and the film cartridge, it needs to be measured during the X-ray imaging and entered as the clearance parameters (d) or (e).

All the numbers should be entered into each field on the screen below.



X-ray image should be selected from the

pictures. If a new X-Ray image will be

uploaded, the ‘Upload’ button

should be clicked.

If the ‘Select’ button is clicked, this pop-

up window will appear.

X-ray image should be selected from

the pictures. To upload a new X-ray

image, select the Upload button.

If the Select button is clicked, a

pop-up window will appear.

X-ray image should be selected from the

pictures. If a new X-Ray image will be

uploaded, the ‘Upload’ button

should be clicked.

If the ‘Select’ button is clicked, this pop-

up window will appear.

Select the correct image for

calculation, followed by the Done

button.

Select the correct image for calculation and then the ‘Done’

button should be clicked.

A new X-ray image should be uploaded from the computer

through this window.



Select the correct image for calculation and then the ‘Done’

button should be clicked.

A new X-ray image should be uploaded from the computer

through this window.

A new X-ray image should be uploaded from the computer through this window.



After X-ray image selected/uploaded

When the X-ray image appears, it should be overlayed onto the

Click 2 Correct template.

Arrows allow circular movement to rotate.

The first bar is for sizing.

The second bar is for transparency

adjustment during the overlaying process.

If the x-ray image doesn’t fit on the

template, the highest point and clearance

values can be adjusted slightly.

When the X-ray image appears, it should be overlayed onto the Click2CorrectTM template.

If the X-ray image does not fit on the template, the highest point and clearance values can be adjusted slightly.

Arrows allow for circular movement to rotate.

The first bar is for sizing.

The second bar is for transparency adjustment during the overlaying process.



After overlaying ends successfully, change the transparency to

full image view.

Locate and identify the individual bone

segment axises to be corrected. Align the two lines, by clicking on the`Mark` button

to bring the bone segment axis lines

into one axis.

The bone segment axises should be

positioned as mid-diaphyseal lines if there is no virtual

deformity correction requirement

Enter the distraction requirement to be

achieved at the end of correction period

Enter the rotational correction

requirement and its direction to be

achieved at the end of correction period.

After overlaying is successfully completed, change the transparency to full image view.

Locate and identify the individual bone segment axes to be corrected.

Align the two lines by clicking on the ‘Mark’ button and bringing the bone segment axes lines into a single axis.

The bone segment axes should be positioned as mid-diaphyseal lines if there is no virtual deformity correction requirement.

Enter the distraction requirement to be achieved at the end of the correction period.

Enter the rotational correction requirement and its direction to be achieved at the end of the correction period.

After overlaying ends successfully, change the transparency to

full image view.

Locate and identify the individual bone

segment axises to be corrected. Align the two lines, by clicking on the`Mark` button

to bring the bone segment axis lines

into one axis.

The bone segment axises should be

positioned as mid-diaphyseal lines if there is no virtual

deformity correction requirement

Enter the distraction requirement to be

achieved at the end of correction period

Enter the rotational correction

requirement and its direction to be

achieved at the end of correction period.



Correction & Prescription

The software calculates a

recommended day number for 1mm

and/or 1° per day. It can be changed

according to user planning.

A starting day should be selected

accordingly and click on the `Calculate &

Save` button for prescription and to

save the case.

The prescription can be printed or e-mailed to

the patient.

Click the `Revise` button to revise/

correct all the parameters and re-

calculate the prescription.

Bone segment movement shows the

daily bone move distance per day in

millimeters.

The prescription shows the strut length

changes and strut type changes.

Correction and PrescriptionThe software calculates a recommended day number for 1mm and/or 1o per day. It can be changed according to user planning.

A starting day should be selected accordingly.

Click on the Calculate & Save button for a prescription and to save the case.

Click the Revise button to revise/correct any parameters and/or to re-calculate the prescription.

The prescription shows the strut length changes and strut type changes.

The prescription can be printed or emailed to the patient.

Bone segment movement shows the daily bone move distance per day in millimeters.

Correction & Prescription

The software calculates a

recommended day number for 1mm

and/or 1° per day. It can be changed

according to user planning.

A starting day should be selected

accordingly and click on the `Calculate &

Save` button for prescription and to

save the case.

The prescription can be printed or e-mailed to

the patient.

Click the `Revise` button to revise/

correct all the parameters and re-

calculate the prescription.

Bone segment movement shows the

daily bone move distance per day in

millimeters.

The prescription shows the strut length

changes and strut type changes.



Revise Calculation Scenario #1: At the beginning of the correction

If revision day `0` is chosen, X-ray images will be kept for re-calculation and the `Deformity` tab will be in `Checked`. Any mistake the user wants to correct with data entry and /or any correction plan changes can be made.

Enter the day number of revisions you want to create. All the strut length parameters will be updated with the

values of the day of revision.

Revise Calculation

Enter the start day number of revisions to be created.

All strut length parameters will be updated with the values of the day of revision.

Note: Highlighted boxes within the prescription indicate when a strut exchange needs to take place. Red boxes indicate that an immediate exchange is necessary (refer to Strut Exchange section).

Scenario #1: At the beginning of the correction

If revision day ‘0’ is chosen, X-ray images will be kept for re-calculation and the Deformity tab will “checked”.

The user may also correct any mistakes with data entry and/or make changes to the correction plan at this time.

Revise Calculation Scenario #1: At the beginning of the correction

If revision day `0` is chosen, X-ray images will be kept for re-calculation and the `Deformity` tab will be in `Checked`. Any mistake the user wants to correct with data entry and /or any correction plan changes can be made.

Enter the day number of revisions you want to create. All the strut length parameters will be updated with the

values of the day of revision.



Scenario #2: During the correction

If any revision day, (except for `0`), is chosen, X-ray images will not be available for this calculation and need to be updated. Because if a revision occurs during the correction, bone positions will be changed and x-ray images should be renewed for re-calculation. The `Deformity` tab will be `UnChecked`. The case will be like a new case except for the frame parameters.

Deformity page parameters will

appear be coming to be renewed due to

revision request during the correction

Note: Parameters within the

Deformity tab will reset to

“0” due to revision requested

during the correction.


Revise Calculation


If any revision day, (except for `0`), is chosen, X-ray images will not be available for this calculation and need to be updated. Because if a revision occurs during the correction, bone positions will be changed and x-ray images should be renewed for re-calculation. The `Deformity` tab will be `UnChecked`. The case will be like a new case except for the frame parameters.

Deformity page parameters will

appear be coming to be renewed due to

revision request during the correction

If any revision day (except for ‘0’) is chosen, X-ray images will not be available for this calculation and must be updated.

If a revision occurs during the correction, bone positions will be altered and X-ray images should be refreshed for re-calculation. The Deformity tab will be “unchecked” and the case will present like a new case, except for the frame parameters.



Revision History All the revision records will be saved and the user may see all the details of the revisions on the `Start`tab. The last revision will be available to be deleted but the others will not be deleted.

Patient Transfer If the patient records need to be transferred to another Smart Correction software user account, the `Patient`tab will need to be clicked on main header and the `Double Arrow` button should be clicked. A user name or e-mail address should be written to transfer. Other users can be notified if the check box will be activated.

Revision History

Revision History All the revision records will be saved and the user may see all the details of the revisions on the `Start`tab. The last revision will be available to be deleted but the others will not be deleted.

Patient Transfer If the patient records need to be transferred to another Smart Correction software user account, the `Patient`tab will need to be clicked on main header and the `Double Arrow` button should be clicked. A user name or e-mail address should be written to transfer. Other users can be notified if the check box will be activated.

Patient Transfer

All revision records will be saved and the user may view details of the revision(s) in the Start tab. The latest revision may be deleted, but the user is not permitted to delete any earlier revisions.

To transfer patient records to another user account, open the Patient tab and click on the “double arrow” (>>) button. Then, enter the recipient’s Smart Correction® username or email address. The recipient will be notified.



Preoperative Planning Interface Instructions

To access instructions for the Preoperative Planning Interface online, simply click on the Images tab.

ConsultationTo seek consultation from another approved Click2CorrectTM user, the case may be shared via the software. From HIPAA law perspective, the case can be shared without patient data attached. It can also be decided if the shared approved user may perform edits to the record.

Images that have already been uploaded to the users profile can be viewed, calibrated, measured, and edited.

Preoperative Planning Interface Instructions You can easily click on ‘i’ button to proceed instructinos of PreOperative Planning Interface online.

After you click the ‘i’ sign, the following screen will appear and you can choose the instruction topic from the right column of the screen.


1. GRANT OF LICENSE Subject to the payment of the applicable license fees and all the terms and conditions of this End User License Agreement (“EULA”), Response Ortho, LLC (“Response Ortho”), a subsidiary of WishBone Medical, Inc., grants to you a limited, non-exclusive, revocable, non-transferable, non-sublicensable license to use, in binary executable form, the Response Ortho product (“Smart Correction”) that accompanies this EULA. If Click2Correct and all associated applications are licensed as a suite or bundled with more than one specified Click2Correct, this license applies to all such specified Products, subject to any restrictions or usage terms specified on the applicable Purchase Order that apply to any of such Products individually. Notwithstanding the foregoing, to the extent Software Templates (or “Libraries”) are included with the Products and subject to the payment of the applicable license fees and all the terms and conditions of this EULA, specifically but not limited to Section 8, Response Ortho grants to you a limited, term-based, non-exclusive, revocable, non- transferable, non-sublicensable subscription license to install and use the Libraries. 2. PRECAUTIONS AND PERMITTED USES Click2Correct and all associated applications may be used only for the intended uses specified in the user manual of Click2Correct. Click2Correct and all associated applications may be used only by trained personnel, who are qualified, licensed and experienced in conducting the relevant medical procedures. Click2Correct and all associated applications may be used only after thorough review of, and strictly in accordance with, the user manual. All results provided by the Click2Correct and all associated applications must be clinically verified and checked before patient treatment. Click2Correct and all associated applications are evaluation tools, intended to provide aid and support to trained personnel, and should not be used as a decision-making tool. 3. LIFE SUPPORT PROCEDURES AND HIGH-RISK ACTIVITIES You acknowledge that the Click2Correct and all associated applications are not fault tolerant and should not be used in direct life support procedures or other activities requiring fail-safe performance in which the failure Click2Correct could lead directly to death, and you agree not to use or allow the use of the Click2Correct and all associated applications for, or in connection with, any such procedure or activity. 4. OWNERSHIP; COPYRIGHT PROTECTION Click2Correct and all associated applications are not for sale or rent. As between the parties, all titles, ownership rights, and intellectual property rights (including all copyrights, patents, trade secret rights and trademarks) in and to Click2Correct and any copies or portions thereof, shall remain in Response Ortho, its affiliates, or their respective suppliers and licensors. Your possession or use of Click2Correct and all associated applications does not transfer to you any title to the intellectual property in Click2Correct and all associated applications, and you will not acquire any rights to Click2Correct except as expressly set forth in this EULA. Click2Correct and all associated applications are protected by copyright laws and all other applicable laws. Therefore, you must treat the Click2Correct like any other copyrighted material (e.g., a book or musical recording). You may not distribute to any third party any activation mechanism or key supplied by, or on behalf of, Response Ortho, its suppliers, resellers or distributors, in order to activate the copy of Click2Correct that you have licensed. You may not copy the Click2Correct manual(s), on-line documentation, Libraries, or any written materials accompanying Click2Correct and all associated applications. All title and intellectual property rights in and to the content which may be accessed through use of the Click2Correct and all associated applications, including the Libraries, are the property of the respective content owner and may be protected by applicable copyright or other intellectual property laws and treaties. This EULA grants you no rights to use such content, except the right to download and use the Libraries in strict compliance with the license granted hereunder.

SOFTWARE LICENSE AGREEMENT


5. RESTRICTIONS Except as expressly and unambiguously permitted by this EULA, you may not, nor permit anyone else to, directly or indirectly: (a) rent, lease, sublicense, or use Click2Correct and all associated applications for timesharing or service bureau purposes, or otherwise use Click2Correct for any commercial purpose or on behalf of any third party; (b) transfer, assign, or pledge your rights under this EULA, without obtaining the prior written consent of Response Ortho; (c) reverse engineer, decompile, disassemble or otherwise attempt to discover the source code or structure, sequence and organization of Click2Correct and all associated applications (except where the foregoing is required by applicable local law, and then only to the extent so permitted); (d) integrate, incorporate or bundle Click2Correct and all associated applications into any other software or include Click2Correct and all associated applications in other software or hardware without receiving the prior written consent of Response Ortho; (e) disclose the results of any benchmark test Click2Correct and all associated applications to any third party without the prior written approval of Response Ortho; (f) publish reviews of Click2Correct and all associated applications without the prior consent of Response Ortho. You acknowledge that the source code form of Click2Correct remains a confidential trade secret of Response Ortho and/or its affiliates or suppliers. You must maintain all copyright and other any other proprietary notices on Click2Correct and must reproduce such notices exactly on all permitted copies of Click2Correct. 6. TERM AND TERMINATION This EULA shall continue until terminated as set forth in this section. You may terminate this EULA at any time by cancelling the user registration of Click2Correct and all associated applications and Click2Correct documentation. Response Ortho may terminate this EULA immediately if you violate any provision of this EULA. Any termination of this EULA shall also terminate the licenses granted hereunder. Upon termination of this EULA for any reason, you agree Response Ortho to destroy all of your records on Click2Correct and all associated applications. 7. REPORTS You agree to prepare and submit to Response Ortho full and accurate reports, immediately upon becoming aware of any adverse effect occurring during procedures in which results of Click2Correct and all associated applications were used or during any other use of the Click2Correct. 8. INDEMNITY You agree that Response Ortho shall have no liability whatsoever for any use you or any third party makes of Click2Correct and all associated applications. You hereby agree to defend, indemnify, and hold harmless Response Ortho from any and all damages, liability, costs, and expenses (including attorney’s fees) arising from claims related to your use, and your personnel’s use, of the Click2Correct and all associated applications. 9. LIMITED WARRANTY AND WARRANTY DISCLAIMERS The warranty contained in this Section is Response Ortho’s sole obligation and your exclusive remedy for any failure of Click2Correct and all associated applications to perform as warranted. Response Ortho does not warrant that the Click2Correct and all associated applications are error free. This limited warranty is void if failure of Click2Correct has resulted from accident, abuse, or misapplication. EXCEPT AS EXPLICITLY SET FORTH IN THIS AGREEMENT, CLICK2CORRECT AN ALL ASSOCIATED APPLICATIONS ARE PROVIDED “AS IS”. RESPONSE ORTHO DOES NOT WARRANT THAT THE CLICK2CORRECT IS ERROR-FREE. ADDITIONALLY, RESPONSE ORTHO DISCLAIMS ALL WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, PERFORMANCE, ACCURACY, RELIABILITY AND NON-INFRINGEMENT. RESPONSE ORTHO RESERVES THE RIGHT TO ALTER THE CONTENT OR STRUCTURE OF SMART CORRECTION, LIBRARIES AND SERVICES IN USE ON THE DATE HEREOF OR THEREAFTER. THIS DISCLAIMER OF WARRANTY CONSTITUTES AN ESSENTIAL PART OF THIS AGREEMENT. SOME JURISDICTIONS DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS SO THE FOREGOING LIMITATIONS MAY NOT APPLY TO YOU.

SOFTWARE LICENSE AGREEMENT (CONT.)


10. LIMITATION OF LIABILITY UNDER NO CIRCUMSTANCES AND UNDER NO LEGAL THEORY, INCLUDING, BUT NOT LIMITED TO, TORT, CONTRACT, NEGLIGENCE, STRICT LIABILITY, OR OTHERWISE, SHALL RESPONSE ORTHO OR ITS AFFILIATES, SUPPLIERS BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES WHATSOEVER (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOST PROFITS, BUSINESS INTERRUPTION, LOSS OF GOODWILL, ACCURACY OF RESULTS, COMPUTER FAILURE, OR MALFUNCTION), OR DAMAGES ARISING OUT OF THE USE OF OR INABILITY TO USE CLICK2CORRECT AND ALL ASSOCIATED APPLICATIONS, EVEN IF RESPONSE ORTHO HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE FOREGOING LIMITATIONS SHALL APPLY EVEN IF RESPONSE ORTHO SHALL HAVE BEEN INFORMED OF THE POSSIBILITY OF SUCH DAMAGES AND NOTWITHSTANDING THE FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATIONS AND EXCLUSIONS MAY NOT APPLY TO YOU. THESE LIMITATIONS REPRESENT A VOLUNTARY AND MUTUALLY AGREED ALLOCATION OF RISK AND RESPONSIBILITY IN A REASONABLE MANNER HAVING DUE REGARD TO THE RATES AND PRICES CHARGED BY RESPONSE ORTHO. 11. MISCELLANEOUS This EULA represents the complete agreement concerning the license between you and Response Ortho and supersedes all prior agreements and representations between you and Response Ortho. It may be amended only by a writing executed by you and Response Ortho. If any provision of the EULA is held to be unenforceable for any reason, such provision shall be reformed only to the extent necessary to make it enforceable. The failure of Response Ortho to act with respect to a breach of this EULA by you or others does not constitute a waiver and shall not limit the rights of Response Ortho with respect to such breach or any subsequent breaches. This EULA is personal to you and may not be assigned or transferred for any reason whatsoever without the consent of Response Ortho and any action or conduct in violation of the foregoing shall be void and without effect. Response Ortho expressly reserves the right to assign this EULA and to delegate any of its obligations hereunder. This EULA is governed by and construed under the laws of United States. Should you have any questions concerning this EULA, or if you desire to contact Response Ortho for any reason, please contact your distributor or contact Response Ortho, as appropriate, directly at: [email protected], or by calling +90 216 314 1104.

Response Ortho, LLC ITOSB, 10. Cadde, No:1 Tuzla, 34959, Istanbul TURKEY

WishBone Medical, Inc. 100 Capital Drive Warsaw, IN 46582 USA

SOFTWARE LICENSE AGREEMENT (CONT.)

10. LIMITATION OF LIABILITY UNDER NO CIRCUMSTANCES AND UNDER NO LEGAL THEORY, INCLUDING, BUT NOT LIMITED TO, TORT, CONTRACT, NEGLIGENCE, STRICT LIABILITY, OR OTHERWISE, SHALL RESPONSE ORTHO OR ITS AFFILIATES, SUPPLIERS BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES WHATSOEVER (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOST PROFITS, BUSINESS INTERRUPTION, LOSS OF GOODWILL, ACCURACY OF RESULTS, COMPUTER FAILURE, OR MALFUNCTION), OR DAMAGES ARISING OUT OF THE USE OF OR INABILITY TO USE CLICK2CORRECT AND ALL ASSOCIATED APPLICATIONS, EVEN IF RESPONSE ORTHO HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE FOREGOING LIMITATIONS SHALL APPLY EVEN IF RESPONSE ORTHO SHALL HAVE BEEN INFORMED OF THE POSSIBILITY OF SUCH DAMAGES AND NOTWITHSTANDING THE FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATIONS AND EXCLUSIONS MAY NOT APPLY TO YOU. THESE LIMITATIONS REPRESENT A VOLUNTARY AND MUTUALLY AGREED ALLOCATION OF RISK AND RESPONSIBILITY IN A REASONABLE MANNER HAVING DUE REGARD TO THE RATES AND PRICES CHARGED BY RESPONSE ORTHO. 11. MISCELLANEOUS This EULA represents the complete agreement concerning the license between you and Response Ortho and supersedes all prior agreements and representations between you and Response Ortho. It may be amended only by a writing executed by you and Response Ortho. If any provision of the EULA is held to be unenforceable for any reason, such provision shall be reformed only to the extent necessary to make it enforceable. The failure of Response Ortho to act with respect to a breach of this EULA by you or others does not constitute a waiver and shall not limit the rights of Response Ortho with respect to such breach or any subsequent breaches. This EULA is personal to you and may not be assigned or transferred for any reason whatsoever without the consent of Response Ortho and any action or conduct in violation of the foregoing shall be void and without effect. Response Ortho expressly reserves the right to assign this EULA and to delegate any of its obligations hereunder. This EULA is governed by and construed under the laws of United States. Should you have any questions concerning this EULA, or if you desire to contact Response Ortho for any reason, please contact your distributor or contact Response Ortho, as appropriate, directly at: [email protected], or by calling +90 216 314 1104.

Response Ortho, LLC ITOSB, 10. Cadde, No:1 Tuzla, 34959, Istanbul TURKEY

WishBone Medical, Inc. 100 Capital Drive Warsaw, IN 46582 USA

SURGICAL TECHNIQUEFOOT FRAME


Select the appropriate proximal ring and slide over the affected limb (fig. 2).

Proximal Ring

fig. 1

fig. 2

1

Ring diameter needs to allow at least 2cm (two fingers) of distance between the skin and the ring circumferentially (fig. 1).

Ring Selection

fig. 3

Select the appropriate size of foot ring, ensuring to have at least 2cm between the skin and ring (fig. 3).

Select Foot Ring2

SURGICAL TECHNIQUEFOOT FRAME


TABLE OF CONTENTS

SMART CORRECTION | SURGICAL TECHNIQUE

SURGICAL TECHNIQUEFOOT FRAME (CONT.)

59

fig. 4

3

Position ring so that the foot is centered and parallel (fig. 4).

Position Foot Ring

Wire Selection and Placement4

Insert wire under power through the posterior calcaneus in line with the foot ring (fig. 5).

Wire Insertion

fig. 5

5

Wires are offered in standard and olive configurations in two different diameters: 1.6mm and 2.0mm.

Consider patient anatomy prior to selecting wire size.

Note: If using an olive wire, wire stopper washers are available for use. Insert the washer onto the sharp end of the olive wire prior to wire insertion.

Caution: Ensure sufficient fixation internal/external to the frame. It is recommended to insert a minimum of four points of fixation per foot ring.

TABLE OF CONTENTS



60

Connect the wire to the foot ring using the Standard Wire Clamps (fig. 6).

Note: Ensure clamps are not at the end of the foot ring such that it can be closed off, per Step 7 below.

Wire Connection6

fig. 6

7

Foot rings must be closed off. To close off the foot ring, cubes should be attached to the hole closest to the end of the foot ring. From here, insert pin sleeve through cube holes, then insert threaded rod through the pin sleeves, securing with set screws (fig. 7).

Note: A 200mm threaded rod is suggested for use with all sizes of foot rings.

Warning: Foot ring must be closed off prior to tensioning of wires.

Close Off Foot Ring

fig. 7

Shown: Foot ring with cubes assembled with threaded rod. In certain circumstances, supplemental fixation should be considered. Construct design and weight bearing protocols are to be determined at the surgeon’s discretion.

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Position tensioner over the wire from the tensioning side of the ring. Select desired wire tensioner head ( Tensioner Head or Fork Tensioner Head). Ensure tensioner tip is in contact with the clamp or ring before tensioning (fig. 9).

The wire tensioner contains markings to indicate amount of tension from 0-125kg. Wires are recommended to be tensioned between 70-125kg.

Tensioning9

fig. 9

While using one box end of the 10mm Hex Bolt Wrench to maintain the position of the clamp, use another 10mm wrench to tighten the nut (fig. 8). Fully tighten the nut opposite of where the tensioner will be applied.


Tightening Standard Clamps and Connectors

fig. 8

8

Caution: If using an olive wire, consider the intended use of the wire within the correction and if a wire stopper washer was used prior to tensioning. Etched lines are present on the wire to indicate which side of the bone the olive is on.

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Tighten the nut to secure the wire clamp on the side of the tensioner to the ring (fig. 10).


Tighten Wire Bolt and Nut10

fig. 10

Wire Trimming11

fig. 11

Using the Wire Cutter/Plier, cut the end of the wire leaving enough length to allow for additional tensioning on at least one side if needed (fig. 11).

Wire covers are available for patient comfort.

Remaining Half Pin(s) and Wire(s)

Insert additional half pins or wires, being careful to avoid planned location of struts.

Caution: Ensure sufficient fixation internal/external to the frame. It is recommended to insert a minimum of three points of fixation per circular ring and a minimum of four points of fixation per foot ring.

12

Trim excess length of wires and/or half pins using the Wire Cutter/Plier or Rod Cutter (fig. 21).

Half pin and wire covers are available for patient comfort.

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Fix Struts to Outer RingThe struts must be installed and fixed to the outer ring a rough triangular geometric configuration. The struts should be placed in pairs approximately equidistant around the circumference of the ring and secured to the ring using Shoulder Bolts (fig. 13). Tighten Shoulder Bolts using two 10mm wrenches.


The modular nature of the Smart Correction System allows surgeons to choose the final position of the struts, allowing the struts in a particular pair to be separated by a number of holes for easy access to potential wound sites or skin flaps.

Note: Different diameter rings can be used in the same frame as needed. Full rings may also be combined with 2/3 or foot rings.

Note: A surgeon must use the recommended six struts and placed in numbered holes.

14

fig. 13

Select the Appropriate Struts

Note: Consider correction goals when selecting strut size and starting position to avoid frequent strut exchanges (fig. 12).

fig. 12

Distal Use - Anterior Open

Foot Ring Size S1 & S2 S3 & S4 S5 & S6

S - 105mm 9 & 20 19 & 24 13 & 8

M - 120mm 10 & 23 22 & 17 16 & 9

L - 135mm 11 & 26 25 & 19 18 & 10

13

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Thread Appropriate Bolts

Adjust Struts to Foot Ring

Use Wrenches to Tighten Strut

Align the strut with the intended ring hole. Position the strut so that length indicator is visible (fig. 14).

Align Strut15

16

17

18

Thread the appropriate size Shoulder Bolt into the strut through the outer hole in the ring (fig. 15).

• 6mm Shoulder Bolts (silver) are to be used with full rings (6mm thickness) (fig. 15A).

• 8mm Shoulder Bolts (purple) are to be used with 1/3, 2/3 and foot rings (8mm thickness) (fig. 15B).

fig. 14

fig. 16

Repeat Steps 13-16 for each strut.

Warning: Washers cannot be used at strut attachment sites.

Use two 10mm wrenches to tighten the Shoulder Bolts (fig. 16).

An 8Nm Torque Limiting Ratchet Wrench is available for Shoulder Bolt tightening.

fig. 15A fig. 15B

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19

20

fig. 17

Warning: Express Strut prescription is to be made at the surgeon's discretion. Patients that may attempt unauthorized adjustments and patients with mental, physical, or neurological conditions which may impair the ability to cooperate with the postoperative regimen may not be suitable for use of these devices.

Note: The Express Strut locking collar is designated by straight knurls.

If using an Express Strut, tighten strut locking collar counterclockwise until strut height is fixed in place such that no gross adjustments can be made (fig. 17).

Tighten Locking Collar

Re-Tighten Each Bolt and Nut

fig. 18

All nuts and bolts should be fully tightened with the 10mm Hex Bolt Wrench. The 13mm Hex Bolt Wrench is available for counter-torque on cubes and pin clamps (fig. 18).



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21 Consider Mounting a 2nd Level of Fixation to Increase Stability

A full ring can be built above a previously affixed ring using a 2/3 and 1/3 ring of the same size with the 1/3-2/3 ring connector, 20mm (green) connection bolts (x2) and nuts (x2) (fig. 19).

Partial rings may be attached to the frame using struts or threaded rods in approximate equidistant position (fig 20).

Nuts are available to be placed on either side of the ring-threaded rod attachment site.

Dual Rod Connectors (Optional)

If desired threaded rod length is unavailable, dual rod connectors may be used to connect two threaded rods together to create an overall length up to 300mm.

The threaded rods should be fully threaded into the connector such that the ends of the threaded rods are touching at the approximate center of the dual rod connector. Nuts are available to be placed on either side of the dual rod connector to assist with locking in place the position of the dual rod connector.

fig. 20

fig. 19

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23 Patient Safety & ComfortPin and wire covers are available to place at the end of cut half pin and wires.

Sponges and sponge clips are available for use at anchorage insertion sites to aid with pin site maintenance (fig. 24). Sponges can be placed on the insertion site with sponge clips available to attach to the anchorage element to hold the sponge in place.

22 Walking Foot AttachmentThe walking foot attachment is available for attachment to the foot ring as necessary. The walking foot attachment should be positioned on the single hole rows of the foot ring and should have 4-5 ring holes between the attachment sites (fig. 21). Consider walking foot attachment placement prior to final tightening of clamps, struts, and threaded rods on the foot ring.

Threaded rods should be used through the ring holes and walking foot attachment holes. Standard nuts should be used on the bottom side of the walking foot attachment and assembled first (fig. 22).

Dual rod connectors (20mm, 40mm, 60mm) are available to add between the ring and walking foot attachment as necessary to lift the foot off of the ground up to 60mm and/or to connect the Walking Foot Attachment.

Standard or Long Nuts should be used at final assembly to attach the threaded rod to the ring from above (fig. 23).

Caution: Weight bearing activities should be permitted at surgeon’s discretion.

fig. 21

fig. 22

fig. 23

fig. 24

1. Advanced Clamps (x2)

2. 10mm Wrench (x2)

3. Threaded Rod: 60-300mm (x1)

4. Nuts (x2)

5. Shoulder Bolts: 6/8mm (x2 per strut exchange)

COMPONENTS NEEDED

SURGICAL TECHNIQUESTRUT EXCHANGE


Insert the Advanced Pin Clamp into the proximal ring as close to the original strut as possible (fig. 1).

Insert Clamps (Proximal Ring)1

A strut exchange may need to be performed during the course of treatment. Additionally, multiple strut exchanges may be necessary during a single event. In order to bridge the frame in the area of the strut exchange, place a temporary support to prevent loss of construct stability.

Repeat this step on the distal ring (fig. 2).

Insert Clamps (Distal Ring)2

Insert the threaded rod through both Advanced Pin Clamps (proximally and distally). Tighten the clamps (fig. 3).

Insert Threaded Rod3

Loosen the Shoulder Bolts on both ends of the strut to be exchanged (fig. 4).

Warning: These Shoulder Bolts should not be reused. New Shoulder Bolts should be utilized when replacing struts.

Loosen Bolts4

fig. 3

fig. 1

fig. 4

SURGICAL TECHNIQUE: STRUT EXCHANGE

fig. 2


Strut should be placed in the same hole locations as the original strut. Strut length should match the designated length on the patient prescription (fig. 6).

Warning: New Shoulder Bolts should be utilized during strut replacement.

Ensure the strut removed matches prescription (fig. 5, fig. 6).

Place New Strut6

Transfer the ID Clip onto the new strut.

Transfer Strut ID Clip7

Perform final tightening on the new strut and Shoulder Bolts using two 10mm Hex Bolt Wrenches.


Final Tightening8

Once the new strut is securely in place, remove the Advanced Pin Clamps and threaded rod.

Remove Temporary Support9

Remove Original Strut5

SURGICAL TECHNIQUESTRUT EXCHANGE (CONT.)

fig. 5

fig. 6

SURGICAL TECHNIQUEHARDWARE REMOVAL


Wire Cutting

Using a 10mm Hex Bolt Wrench, loosen the connections on all half pins. Then, remove the half pins using T-Handle with Jacob’s Chuck (fig. 1).

Cut each wire on both sides approximately 1cm from the skin using the Wire Cutter/Plier.

Pin Removal1

2

Frame RemovalCarefully slide the entire frame off of the affected limb.

Caution: If olive wires were used, take note of which side the olive is on (as indicated by etching on wire) for appropriate removal.

3

Wire RemovalRemove all wires from the patient. Wire Cutter/Plier is available to aid in wire removal.

Caution: If olive wires were used, do not pull the olive through bone. Instead, pull the side with the olive (this is the side with the laser etched bands).

4

Caution: Any wire that is pulled through the bone must be straight and free of debris.

Note: Struts may need to be loosened to facilitate frame removal.

fig. 1

SURGICAL TECHNIQUEHARDWARE REMOVAL


CASE LAYOUTS

ITEM # DESCRIPTION QTY

50-1012-10A-WB Dual Hole Full Ring, 105mm ID, Aluminum 2






Full Aluminum Rings

SC-RINGCASE1NS Smart Correction Full Ring Case

50-1017-10A-WB Dual Hole 2/3 Ring, 105mm ID, Aluminum 1






2/3 Aluminum Rings

SC-RINGCASE2NS Smart Correction Two-Third and Foot Ring Case

SC-CLAMPCASENS Smart Correction Clamps and Bolts Case

50-1041-00-WB Standard Wire Clamp 17

50-1042-30-WB Advanced Pin Clamp 10

50-1042-00-WB Standard Pin Clamp 15

50-1052-01-WB Standard Nut 60

50-1053-12-WB Connection Bolt, Short, 12mm 20

50-1053-16-WB Connection Bolt, Medium, 16mm 10

50-1053-20-WB Connection Bolt, Long, 20mm 10

50-1153-06-WB Shoulder Bolt - 6mm 30

50-1153-08-WB Shoulder Bolt - 8mm 30

50-1051-00-WB Washer 60

50-1015-01-WB Foot Ring, Small, Aluminum 1

50-1015-03-WB Foot Ring, Medium, Aluminum 1

50-1015-02-WB Foot Ring, Large, Aluminum 1

Aluminum Foot Rings



50-1032-01-WB Dual Joint Exp. Strut, XShort 6

50-1032-02-WB Dual Joint Exp. Strut, Short 12

50-1032-03-WB Dual Joint Exp. Strut, Medium 18

50-1032-04-WB Dual Joint Exp. Strut, Long 6

Dual Joint Struts

SC-STRUTCASENS Smart Correction Strut Case

50-1057-60S-WB Threaded Rod, 60mm length, SS 6







Threaded Rods

SC-PINCASENS Smart Correction Pins and Wires Case

50-1071-16S-WB Wire - 1.6mm, Bayonet Tip, SS 10

50-1071-20S-WB Wire - 2.0mm, Bayonet Tip, SS 10

50-1072-16S-WB Olive Wire - 1.6mm, Bayonet Tip, SS 4

50-1072-20S-WB Olive Wire - 2.0mm, Bayonet Tip, SS 4

50-1850-204S-WB Half Pin, 5.0/200/40mm, Self Drilling, QC, SS 6



Wires

Half Pins

00-6200-32-WB AO Drill Bit 3.2 x 200mm 2

00-6200-48-WB AO Drill Bit 4.8 x 200mm 2

Drill Bits

CASE LAYOUTS (CONT.)


00-2055-13-WB 13mm Hex Bolt Wrench 1

00-2055-10R-WB 10mm Hex Bolt Ratchet Wrench 1

00-2055-10S-WB 10mm Socket Wrench 1

00-2054-10-WB Slotted Wrench 1

00-2055-10-WB 10mm Hex Bolt Wrench 2

00-2033-15T-WB T-Allen Wrench, 3mm/150mm 1

00-1043-AO-WB T-Handle for Half Pins (AO Connector) 1

00-1043-JC-WB T-Handle w/ Jacobs Chuck 1

00-0014-60-WB Depth Gauge, 60mm 1

50-1056-01-WB Cube, 1 Hole 4

50-1056-02-WB Cube, 2 Hole 4

50-1056-03-WB Cube, 3 Hole 4

50-1056-04-WB Cube, 4 Hole 4

50-1056-05-WB Cube, 5 Hole 4

SC-INSTCASE2NS Smart Correction Instrument Case 2


00-0134-40-WB Wire Cutter/Plier 1

00-0046-50-WB Drill Sleeve Handle 1

00-0046-51-WB Drill Sleeve Guide - Long 1

00-0046-52-WB Drill Sleeve Guide - Short 1

00-0046-53-WB Trocar - Long 1

00-0046-54-WB Trocar - Short 1

00-0182-01-WB Single Hand Wire Tensioner 2

00-0182-02-WB Fork Tensioner Head 1

00-0182-03-WB Tensioner Head 1

SC-INSTCASE1NS Smart Correction Instrument Case 1

CASE LAYOUTS (CONT.)

The Smart Correction® System Delivered Goods Form (LIT-DGF-SCEF) is available for ordering information.

Access the document online at www.WishBoneMedical.com/product/SC.

WishBoneMedical.com

100 Capital Drive Warsaw, IN 46582

+1-574-306-4006

All trademarks herein are the property of WishBone Medical, Inc. or its subsidiaries unless otherwise indicated. This material is intended for the sole use and benefit of Health Care Professionals and the WishBone Medical Sales Force. It is not to be redistributed, duplicated or disclosed without the express written consent of WishBone Medical.

For product information, including indications, contraindications, warnings, precautions and potential adverse effects, as well as Patient Instructions for Use, visit WishBone Medical’s Instructions for Use page online: www.WishBoneMedical.com/IFU.

The MR environment presents risks to patients with metal implants. Physicians should consider the risks when recommending MR imaging for patients with metal implants.

The WishBone Medical Smart Correction® System components have not been evaluated for safety and compatibility in MR environment.

© 2021 WishBone Medical, Inc. | LBL-ST-SCEF REV F | 09-2021