4WEB SURGICAL TECHNIQUE - Squarespace · 3 Introduction P.5 P.6 P.10 P.14 Chapter 1 4WEB EOTS for Evans Type Procedures 4WEB COTS for Cotton Type Procedures 4WEB …

OSTEOTOMY TRUSS SYSTEMInstruments and Implants For Osteotomies

4WEB SURGICAL TECHNIQUE

2

3

Introduction P.5

P.6

P.10

P.14

Chapter 14WEB EOTS for Evans Type Procedures

4WEB COTS for Cotton Type Procedures

4WEB UOTS for Hindfoot OpeningWedge Osteotomies

Chapter 2

Chapter 3

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Proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training and experience. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting 4WEB, INC.

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Indications for Use: The 4WEB Osteotomy Truss Cage is intended to be used for internal bone wedge implantation in osteotomies of the foot, such as opening wedge osteotomies in Hallux Valgus correction, Cotton opening wedge osteotomies, and Evans lengthening osteotomies. These devices are intended for use with autograft bone and supplemental fixation. The 4WEB Osteotomy Truss Cage is not intended for use in the spine.

Contraindications: The 4WEB Osteotomy Truss Cage should not be implanted in patients with active infections at the operative site or other active systemic infection; physiologically or psychologically inadequate patient; inadequate skin, bone, or neurovascular status; metal sensitivity to a foreign body; or a growing patient with open epiphyses. Do not attach supplemental fixation hardware to or through the 4WEB device.

Warnings: No implant should be reused if it has come in contact with blood or other bodily fluids. Patients requiring abnormal or excessive forces on the implanted area may not be good candidates for this type of surgery.

Precautions: In patients with a high level of activity, the benefits must be weighed against possible risks. The correct size must be selected to provide adequate bone support. Implants and trial spacers are provided non-sterile and must be steam sterilized prior to use. All implants and trial spacers should be inspected prior to use for possible damage or defects. Any damaged or defective component should not be used and should be returned to the manufacturer. Based on the fatigue testing results, the physician/surgeon should consider the location of implantation, patient weight, patient activity level, other patient conditions, etc. which may have an impact on the performance of the system.

The 4WEB Osteotomy devices have not been evaluated for safety and compatibility in the Magnetic Resonance Imaging (MRI) environment. The 4WEB Osteotomy devices have not been tested for heating or migration in the MRI environment.

Introduction

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4WEBEVANSOSTEOTOMYTRUSSSYSTEMSURGICALTECHNIQUE

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For the Evans Procedure use the EOTS implant set. This set contains 3 footprints as found in the chart below.

EOTS - Standard

Implant Part No.

Footprint(Width x Depth in MM)

Thickness (MM)

EOTS-SM1804 18x18 4.5

EOTS-SM1805 18x18 5.5

EOTS-SM1806 18x18 6.5

EOTS-SM1808 18x18 8

EOTS-SM1810 18x18 10

EOTS-SM1812 18x18 12

EOTS-MD2004 20x20 4.5

EOTS-MD2005 20x20 5.5

EOTS-MD2006 20x20 6.5

EOTS-MD2008 20x20 8

EOTS-MD2010 20x20 10

EOTS-MD2012 20x20 12

EOTS-LG2204 22x22 4.5

EOTS-LG2205 22x22 5.5

EOTS-LG2206 22x22 6.5

EOTS-LG2208 22x22 8

EOTS-LG2210 22x22 10

EOTS-LG2212 22x22 12

Chapter 1 4WEB EOTS for Evans Type Procedures

Thickness

WidthDepth

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The EOTS Implant may be used in an Evans Procedure for lateral column lengthening. However, this general technique can be applied to other opening wedge osteotomies of the foot requiring wedges of similar size.

An incision is made slightly inferior to the sinus tarsi directly over the calcaneal-cuboid joint. Care should be taken during dissection and retraction to protect the peroneal tendons and sural nerve.

STEP 1: ACCESS AND APPROACH


An osteotomy is made 10-15mm proximal to the calcaneal-cuboid joint. Optional provisional pinning of the calcaneal-cuboid joint prior to the osteotomy to stabilize structures and prevent subluxation may be utilized. An osteotome is used to finish the osteotomy taking care to preserve the medial wall of calcaneal cortex.

STEP 2: CREATING THE OSTEOTOMY


A distractor is installed to provide controlled distraction and unobstructed access to the osteotomy site. The surgeon should distract until adequate position of desired correction is achieved.

STEP 3: DISTRACTION

STEP 3: DISTRACTION


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Insert the color specific trials into the osteotomy site until the correct footprint and thickness of the wedge are determined via fluoroscopy and adequacy of feel and friction with trial. The trial determined to be the correct size is the size of implant to be used. Once the implant is identified, proceed to pack the implant with autograft bone.

PACKING INSTRUCTIONSFor best results, cut or morselize the autograft bone into 1-2 mm sized particles.

STEP 4: IMPLANT SIZING AND PREPARATION

A. Place the morselized bone onto the top or bottom web structure (top and bottom are interchangeable).

B. In a downward circular direction, massage the bone particles into the implant using fingers, freer elevator, curette, or forceps.

C. Once packing has been completed through the top web structure, turn device over and repeat steps A and B through the opposite side of the web structure.

D. The implant is now ready for use.


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Contact between supplemental fixation and the wedge is not recommended. Abrasion could cause damage to either of the two devices.

Follow the compression device manufacturer’s surgical technique guide for placement instructions.

Attaching or directing supplemental hardware through the 4WEB bone wedge is not recommended.

Thread the inserter into the implant chosen for use and insert the EOTS osteotomy wedge into the osteotomy site. Seat the implant with a standard bone tamp/impactor until the proximal edge is at least 1.5 mm past the edge of the cortex where supplemental fixation (surgeon’s preference) will be placed to ensure no contact will be made between the fixation device and wedge.

Installation of supplemental fixation is required when using the 4WEB EOTS osteotomy wedges. Any compression-based fixation device that meets the following guidelines may be used:

STEP 5: IMPLANT PLACEMENT


STEP 6: SUPPLEMENTAL FIXATION


Final correction and placement are confirmed fluoroscopically.

+ It is a compression plate or staple.

+ It is NOT bioabsorbable.

+ It is a titanium alloy device.


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4WEBCOTTONOSTEOTOMYTRUSSSYSTEMSURGICALTECHNIQUE

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For the Cotton Procedure use the COTS implant set. This set contains 4 footprints as found in the chart below.

COTS

Implant Part No.


Thickness (MM)

COTS-XS1304 13x11 4.5

COTS-XS1305 13x11 5.5

COTS-XS1306 13x11 6.5

COTS-XS1308 13x11 8

COTS-XS1310 13x11 10

COTS-XS1312 13x11 12

COTS-SM1604 16x14 4.5

COTS-SM1605 16x14 5.5

COTS-SM1606 16x14 6.5

COTS-SM1608 16x14 8

COTS-SM1610 16x14 10

COTS-SM1612 16x14 12

COTS-MD2004 20x14 4.5

COTS-MD2005 20x14 5.5

COTS-MD2006 20x14 6.5

COTS-MD2008 20x14 8

COTS-MD2010 20x14 10

COTS-MD2012 20x14 12

COTS-MD2014 20x14 14

COTS-MD2016 20x14 16

COTS-LG2304 23x17 4.5

COTS-LG2305 23x17 5.5

COTS-LG2306 23x17 6.5

COTS-LG2308 23x17 8

COTS-LG2310 23x17 10

COTS-LG2312 23x17 12

COTS-LG2314 23x17 14

COTS-LG2316 23x17 16

Chapter 2 4WEB COTS for Cotton Type Procedures

Thickness

WidthDepth

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A dorsal incision is made over the medial cuneiform. Carefully retract the hallucis longus tendon and dissect soft tissues down to the surface of the medial cuneiform.



A transverse osteotomy is made starting on the dorsal cortex, angled parallel to the 1st tarsometatarsal joint, and aimed toward the plantar cortex. The cut is stopped before penetrating the plantar cortex and an osteotome is used to finish the wedge osteotomy taking care to preserve the plantar cortex.



A distractor is installed to provide controlled distraction and unobstructed access to the osteotomy site. Care should be taken to preserve the plantar cortex. The surgeon should distract until adequate position of desired correction is achieved.

STEP 3: DISTRACTION

STEP 3: DISTRACTION


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Insert the COTS osteotomy wedge into the osteotomy site. Seat the implant with a standard bone tamp/impactor until the proximal edge is at least 1.5 mm past the edge of the cortex where supplemental fixation (surgeon’s preference) will be placed to ensure no contact will be made between the fixation device and wedge.

Installation of supplemental fixation is required when using the 4WEB COTS osteotomy wedges. Any compression-based fixation device that meets the following guidelines may be used:










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4WEBUTILITYOSTEOTOMYTRUSSSYSTEMSURGICALTECHNIQUE

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For the Opening Wedge Calcaneal Osteotomy, use the UOTS implant set. This set contains 6 footprints as found in the chart below.

UOTS

Implant Part No.


Thickness (MM)

UOTS-XS2004 20x16 4.5

UOTS-XS2005 20x16 5.5

UOTS-XS2006 20x16 6.5

UOTS-XS2008 20x16 8

UOTS-XS2010 20x16 10

UOTS-XS2012 20x16 12

UOTS-SM2204 22x18 4.5

UOTS-SM2205 22x18 5.5

UOTS-SM2206 22x18 6.5

UOTS-SM2208 22x18 8

UOTS-SM2210 22x18 10

UOTS-SM2212 22x18 12

UOTS-MD3006 20x30 6

UOTS-MD3008 20x30 8

UOTS-MD3010 20x30 10

UOTS-MD3012 20x30 12

UOTS-MD3506 20x35 6

UOTS-MD3508 20x35 8

UOTS-MD3510 20x35 10

UOTS-MD3512 20x35 12

UOTS-LG3006 25x30 6

UOTS-LG3008 25x30 8

UOTS-LG3010 25x30 10

UOTS-LG3012 25x30 12

UOTS-LG3506 25x35 6

UOTS-LG3508 25x35 8

UOTS-LG3510 25x35 10

UOTS-LG3512 25x35 12

Chapter 3 4WEB UOTS for Utility Type Procedures

Thickness

Width

Depth

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Intended Use: Correction for hindfoot valgus and lengthening of the lateral column associated with congenital or acquired deformities. The purpose is to restore normal anatomy and subsequently improve biomechanics.

A lateral approach via an oblique incision is made over the lateral aspect of the calcaneus in line with the osteotomy. Care should be taken to avoid the peroneal tendons and sural nerve. Periosteal dissection should be carried out along the calcaneus at the intended osteotomy site.



An opening wedge osteomtomy to correct a valgus deformity is made at the mid portion of the posterior tuberosity halfway between the posterior facet margin and the Achilles insertion. Care is taken not to penetrate the medial cortex.



An osteotome is used to gently open the osteotomy. This is followed by placement of the distraction device.

STEP 3: DISTRACTION

STEP 3: DISTRACTION


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Insert the UOTS osteotomy wedge into the osteotomy site. Seat the implant with a standard bone tamp/impactor until the proximal edge is at least 1.5 mm past the edge of the cortex where supplemental fixation (surgeon’s preference) will be placed to ensure no contact will be made between the fixation device and wedge.

Installation of supplemental fixation is required when using the 4WEB UOTS osteotomy wedges. Any compression-based fixation device that meets the following guidelines may be used:










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IMPLANTS

Implants - COTTON (COTS)

Cotton Wedge

23 x 17mm

H 4.5 COTS-LG2304

H 5.5 COTS-LG2305

H 6 COTS-LG2306

H 8 COTS-LG2308

H 10 COTS-LG2310

H 12 COTS-LG2312

H 14 COTS-LG2314

H 16 COTS-LG2316

Cotton Wedge

20 x 14mm

H 4.5 COTS-MD2004

H 5.5 COTS-MD2005

H 6 COTS-MD2006

H 8 COTS-MD2008

H 10 COTS-MD2010

H 12 COTS-MD2012

H 14 COTS-MD2014

H 16 COTS-MD2016

Cotton Wedge

16 x 14mm

H 4.5 COTS-SM1604

H 5.5 COTS-SM1605

H 6 COTS-SM1606

H 8 COTS-SM1608

H 10 COTS-SM1610

H 12 COTS-SM1612

Cotton Wedge

13 x 11mm

H 4.5 COTS-XS1304

H 5.5 COTS-XS1305

H 6 COTS-XS1306

H 8 COTS-XS1308

H 10 COTS-XS1310

H 12 COTS-XS1312

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Implants - EVANS (EOTS)

Evans Wedge

18 x 18mm

H 4.5 EOTS-SM1804

H 5.5 EOTS-SM1805

H 6 EOTS-SM1806

H 8 EOTS-SM1808

H 10 EOTS-SM1810

H 12 EOTS-SM1812

Evans Wedge

20 x 20mm

H 4.5 EOTS-MD2004

H 5.5 EOTS-MD2005

H 6 EOTS-MD2006

H 8 EOTS-MD2008

H 10 EOTS-MD2010

H 12 EOTS-MD2012

Evans Wedge

22 x 22mm

H 4.5 EOTS-LG2204

H 5.5 EOTS-LG2205

H 6 EOTS-LG2206

H 8 EOTS-LG2208

H 10 EOTS-LG2210

H 12 EOTS-LG2212

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Implants - UTILITY (UOTS)

Utility Wedge

20 x 16mm

H 4.5 UOTS-XS2004

H 5.5 UOTS-XS2005

H 6 UOTS-XS2006

H 8 UOTS-XS2008

H 10 UOTS-XS2010

H 12 UOTS-XS2012

Utility Wedge

20 x 18mm

H 4.5 UOTS-SM2204

H 5.5 UOTS-SM2205

H 6 UOTS-SM2206

H 8 UOTS-SM2208

H 10 UOTS-SM2210

H 12 UOTS-SM2212

Utility Wedge

22 x 30mm

H 6 UOTS-MD3006

H 8 UOTS-MD3008

H 10 UOTS-MD3010

H 12 UOTS-MD3012

Utility Wedge

22 x 35mm

H 6 UOTS-MD3506

H 8 UOTS-MD3508

H 10 UOTS-MD3510

H 12 UOTS-MD3512

IMPLANTS

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Utility Wedge

25 x 30mm

H 6 UOTS-LG3006

H 8 UOTS-LG3008

H 10 UOTS-LG3010

H 12 UOTS-LG3012

Utility Wedge

25 x 35mm

H 6 UOTS-LG3506

H 8 UOTS-LG3508

H 10 UOTS-LG3510

H 12 UOTS-LG3512

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Large Cotton Trial (4.5, 5.5, 6.5) COTS-LG0406-T - (x1)

Large Cotton Trial (8, 10, 12) COTS-LG0812-T - (x1)

Large Cotton Trial (14, 16) COTS-LG1416-T - (x1)

Small Cotton Trial (4.5, 5.5, 6.5) COTS-SM0406-T - (x1)

Small Cotton Trial (8, 10, 12) COTS-SM0812-T - (x1)

Extra Small Cotton Trial (4.5, 5.5, 6.5) COTS-XS0406-T - (x1)

Extra Small Cotton Trial (8, 10, 12) COTS-XS0812-T - (x1)

Medium Cotton Trial (4.5, 5.5, 6.5) COTS-MD0406-T - (x1)

Medium Cotton Trial (8, 10, 12) COTS-MD0812-T - (x1)

Medium Cotton Trial (14, 16) COTS-MD1416-T - (x1)

TRIALS

Cotton Osteotomy Truss System Trials

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Large Evans Trial (4.5, 5.5, 6.5) EOTS-LG0406-T - (x1)

Large Evans Trial (8, 10, 12) EOTS-LG0812-T - (x1)

Medium Evans Trial (4.5, 5.5, 6.5) EOTS-MD0406-T - (x1)

Medium Evans Trial (8, 10, 12) EOTS-MD0812-T - (x1)

Small Evans Trial (4.5, 5.5, 6.5) EOTS-SM0406-T - (x1)Small Evans Trial (8, 10, 12) EOTS-SM0812-T - (x1)

Evans Osteotomy Truss System Trials

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Extra Small Utility Trial (4.5, 5.5, 6.5) UOTS-XS0406-T - (x1)

Extra Small Utility Trial (8, 10, 12) UOTS-XS0812-T - (x1)

Large 30mm Utility Trial (6.5, 8) UOTS-LG3008-T - (x1)

Large 30mm Utility Trial (10, 12) UOTS-LG3012-T - (x1)

Large 35mm Utility Trial (6.5, 8) UOTS-LG3508-T - (x1)

Large 35mm Utility Trial (10, 12) UOTS-LG3512-T - (x1)

Medium 30mm Utility Trial (6.5, 8) UOTS-MD3008-T - (x1)

Medium 30mm Utility Trial (10, 12) UOTS-MD3012-T - (x1)

Medium 35mm Utility Trial (6.5, 8) UOTS-MD3508-T - (x1)

Medium 35mm Utility Trial (10, 12) UOTS-MD3512-T - (x1)

Small Utility Trial (4.5, 5.5, 6.5) UOTS-SM0406-T - (x1)

Small Utility Trial (8, 10, 12) UOTS-SM0812-T - (x1)

TRIALS

Utility Osteotomy Truss System Trials

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Mini-Lambotte Osteotome 4mm - OM 46-0336 - (x1)



Bone Chip Packer 10» 3mm x 16mm - OM 49-0750 - (x1)


Bone Tamp 6» Diam. 2mm Cross Serr. - OM 46-0893 - (x1)


OTS Introducer - UOTS-000002 - (x1)

Instrument Case - 5237-0001000-00 - (x1)

COTS Caddy - 5237-0004370-00 - (x1)

EOTS Caddy - 5237-0004360-00 - (x1)

UOTS Caddy - 5237-0004270-00 - (x1)

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Documents

4WEB SURGICAL TECHNIQUE - Squarespace · 3 Introduction P.5 P.6 P.10 P.14 Chapter 1 4WEB EOTS for Evans Type Procedures 4WEB COTS for Cotton Type Procedures 4WEB …