Inion Freedom™ Resorbable Fixation System · Inion FreedomScrew™ - Fully threaded Art. No. Description . OSA-2010 FreedomScrew 2.0 x 10 mm . OSA-2012 FreedomScrew 2.0 x 12 mm

Inion Freedom™ Resorbable Fixation System

Version 5, 01/2020 &

Clinical considerations

Inion Freedom™

Inion Freedom™ is composed of:

Inion FreedomScrew™ and Inion FreedomPlate™

“One screw and one plate” ideology offers: Low inventory costs and decreased warehouse items Multiple variations for multiple indications Polyaxial and free screw placement Low profile construct (fully customizable plate which contours to all

anatomies and fixation screws which interlock with the plate)

Inion Freedom™

Product Message: Strong and effective fixation system to several different Orthopaedic & Trauma indications.

“Freedom to Operate”

Where? – Indications 1/3


Inion FreedomPlate™ Maintenance of aligment and fixation of bone fractures osteotomies arthrodesis of long bones, flat bones, short bones, irregular bones, appendicular skeleton and thorax, in the presence of appropriate additional immobilization or fixation.

Maintenance of relative position of weak bony tissue in trauma and reconstructive procedures, i.e: bone grafts bone grafts substitutes bone fragments in comminuted fractures


Inion FreedomScrew™ Maintenance of aligment and fixation of bone fractures, comminuted fractures, osteotomies, arthrodesis, or bone grafts (i.e., autografts or allografts) in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast or brace).

In addition, the Inion FreedomScrew™ 3.5/4.0/4.5 mm products are specifically intended for use in following indications: A. General indications: maintenance of reduction and fixation of

cancellous bone fractures, osteotomies or arthrodesis of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization B. Specific indications: fractures and osteotomies of the malleoli, and

ankle fractures

Inion FreedomPlate™

Plates Ref. No. Description

FRF-1065 20x65 mm concave plate

FRF-1066 20x100 mm concave plate

Polymer composition: Copolymer blend of LPLA/DLPLA/TMC. Bioresorption takes place within two to four years.

Inion FreedomScrew™ - Fully threaded Art. No. Description OSA-2014 FreedomScrew 2.0 x 14 mm OSA-2020 FreedomScrew 2.0 x 20 mm OSA-2716 FreedomScrew 2.7 x 16 mm OSA-2740 FreedomScrew 2.7 x 40 mm OSA-3530 FreedomScrew 3.5 x 30 mm OSA-3545 FreedomScrew 3.5 x 45 mm OSA-4540 FreedomScrew 4.5 x 40 mm OSA-4555 FreedomScrew 4.5 x 55 mm

Inion FreedomScrew™ - Partially threaded (LAG), Cannulated Art. No. Description OSD-3530 FreedomScrew 3.5 x 30 mm (LAG) , Cannulated OSD-3535 FreedomScrew 3.5 x 35 mm (LAG), Cannulated OSD-3540 FreedomScrew 3.5 x 40 mm (LAG), Cannulated OSD-3545 FreedomScrew 3.5 x 45 mm (LAG), Cannulated OSD-4535 FreedomScrew 4.5 x 35 mm (LAG), Cannulated OSD-4540 FreedomScrew 4.5 x 40 mm (LAG), Cannulated OSD-4545 FreedomScrew 4.5 x 45 mm (LAG), Cannulated OSD-4550 FreedomScrew 4.5 x 50 mm (LAG), Cannulated OSD-4555 FreedomScrew 4.5 x 55 mm (LAG), Cannulated

Polymer composition: Oriented copolymer of LPLA/DLPLA Bioresorption takes place within two to four years.

Inion FreedomScrew™ - Fully threaded, Cannulated OSC-3530 FreedomScrew 3.5 x 30 mm, Cannulated OSC-3545 FreedomScrew 3.5 x 45 mm, Cannulated OSC-4540 FreedomScrew 4.5 x 40 mm, Cannulated OSC-4555 FreedomScrew 4.5 x 55 mm, Cannulated

Inion FreedomScrew™ - Fully threaded, Cannulated - Syndesmosis Screw Art. No. Description OSC-4090 FreedomScrew 4.0 x 90 mm, Cannulated

Inion FreedomScrew™

Inion FreedomScrew™ - Fully threaded Art. No. Description OSA-2010 FreedomScrew 2.0 x 10 mm OSA-2012 FreedomScrew 2.0 x 12 mm OSA-2016 FreedomScrew 2.0 x 16 mm OSA-2018 FreedomScrew 2.0 x 18 mm OSA-2712 FreedomScrew 2.7 x 12 mm OSA-2714 FreedomScrew 2.7 x 14 mm OSA-2718 FreedomScrew 2.7 x 18 mm OSA-2720 FreedomScrew 2.7 x 20 mm OSA-2725 FreedomScrew 2.7 x 25 mm OSA-2730 FreedomScrew 2.7 x 30 mm OSA-2735 FreedomScrew 2.7 x 35 mm OSA-3520 FreedomScrew 3.5 x 20 mm OSA-3525 FreedomScrew 3.5 x 25 mm OSA-3535 FreedomScrew 3.5 x 35 mm OSA-3540 FreedomScrew 3.5 x 40 mm OSA-4535 FreedomScrew 4.5 x 35 mm OSA-4545 FreedomScrew 4.5 x 45 mm OSA-4550 FreedomScrew 4.5 x 50 mm OSA-4590 FreedomScrew 4.5 x 90 mm

Inion FreedomScrew™ - Fully threaded, Cannulated - Syndesmosis Screw Art. No. Description OSC-3520 FreedomScrew 3.5 x 20 mm, cannul. OSC-3525 FreedomScrew 3.5 x 25 mm, cannul. OSC-3535 FreedomScrew 3.5 x 35 mm, cannul. OSC-3540 FreedomScrew 3.5 x 40 mm, cannul. OSC-4535 FreedomScrew 4.5 x 35 mm, cannul. OSC-4545 FreedomScrew 4.5 x 45 mm, cannul. OSC-4550 FreedomScrew 4.5 x 50 mm, cannul. OSC-4590 FreedomScrew 4.5 x 90 mm, cannul.

Inion FreedomScrew™ (C-categorized products)

Inion FreedomScrew™ - Partially threaded (LAG) Art. No. Description OSB-3520 FreedomScrew 3.5 x 20 mm (LAG) OSB-3525 FreedomScrew 3.5 x 25 mm (LAG) OSB-3530 FreedomScrew 3.5 x 30 mm (LAG) OSB-3535 FreedomScrew 3.5 x 35 mm (LAG) OSB-3540 FreedomScrew 3.5 x 40 mm (LAG) OSB-3545 FreedomScrew 3.5 x 45 mm (LAG) OSB-4535 FreedomScrew 4.5 x 35 mm (LAG) OSB-4540 FreedomScrew 4.5 x 40 mm (LAG) OSB-4545 FreedomScrew 4.5 x 45 mm (LAG) OSB-4550 FreedomScrew 4.5 x 50 mm (LAG) OSB-4555 FreedomScrew 4.5 x 55 mm (LAG)

Inion FreedomScrew™ - Partially threaded (LAG), Cannulated Art. No. Description OSD-3520 FreedomScrew 3.5 x 20 mm (LAG), cannul. OSD-3525 FreedomScrew 3.5 x 25 mm (LAG), cannul.

IFS-2001 Drill bit Ø1.5 mm IFS-2002 Tap Ø2.0 mm IFS-2006 Drill tap Ø2.0 mm IFS-2701 Drill bit Ø2.0 mm IFS-2702 Tap Ø2.7 mm IFS-2706 Drill tap Ø2.7 mm IFS-3501 Drill bit Ø2.5 mm IFS-3502 Tap Ø3.5 mm IFS-3503 Drill bit Ø2.7 mm, cannulated IFS-3504 Tap Ø3.5 mm, cannulated IFS-3506 Drill tap Ø3.5 mm IFS-3508 Drill tap Ø3.5 mm, cannulated IFS-4004 Tap Ø4.0 mm, cannulated IFS-4008 Drill tap Ø4.0 mm, cannulated IFS-4501 Drill bit Ø3.2 mm IFS-4502 Tap Ø4.5 mm IFS-4503 Drill bit Ø3.2 mm, cannulated IFS-4504 Tap Ø4.5 mm, cannulated IFS-4506 Drill tap Ø4.5 mm IFS-4508 Drill tap Ø4.5 mm, cannulated IFS-9001 Screwdriver shaft, hex 2.5 mm IFS-9002 Screwdriver shaft, hex 3.5 mm, cannulated IFS-9011 Holding sleeve for Ø2.0/2.7 mm screws IFS-9012 Holding sleeve for Ø3.5 - 4.5 mm screws IFS-9021 Drill sleeve Ø1.5/2.0 mm, for Ø2.0 mm screws IFS-9022 Drill sleeve Ø2.0/2.7 mm, for Ø2.7 mm screws IFS-9023 Drill sleeve Ø2.5 - 3.5 mm, for Ø3.5 mm screws IFS-9024 Drill sleeve Ø3.2 - 4.5 mm, for Ø4.0/4.5 mm screws IFS-9031 Countersink for Ø2.0/2.7 mm screws IFS-9032 Countersink for 3.5 - 4.5 mm screws, cannulated IFS-9041 Depth gauge for Ø2.7/3.5 mm screws

IFS-9042 Depth gauge for Ø2.7 - 4.5 mm screws ,with K-wire IFS-9043 K-wire Ø1.6 mm (used with depth gauge) IFS-9051 Screw cutting pliers IFS-9052 Scale for Ø2.0/2.7 mm screws IFS-9053 Scale for Ø3.5 - 4.5 mm screws INS-9093 Small handle, cannulated (set contains two pieces of INS-9093) INS-9120 Large handle, cannulated IFS-9801 Instrument tray IFS-9901 FULL - FreedomScrew Instrument set with tray HTC-0000 Low Temperature Cautery (10 pcs.) ACC-9802 Inion Thermo drape (5 drapes) ACC-9810 Inion Thermo+ water bath (230 V+EU plug) ACC-9840 Inion Thermo+ water bath (110V+US plug) IFS-9061 K-wire Ø1.25 mm (10 pieces) IFS-9062 K-wire Ø1.6 mm (10 pieces)

Inion FreedomScrew™ Instruments 1/2

Inion FreedomScrew™ Drill Taps and Bone taps:

Drill tap - Drill and tap combined: Drilling and tapping performed simultaneously

with one instrument The additional step of manual tapping removed Yellow stripe to separate the Drill tap from the

Bone tap Use of the Bone taps and Drill taps: The Drill tap and Bone tap are designed to be

used with the Drill sleeve instrument The depth markings can be read on the tap shaft

at 5 mm increments, when used with the Drill sleeve

The Drill sleeve prevents instrument-wobble and protects surrounding soft tissues. It can be used to press the plate tightly against the bone to ensure continuous thread through the plate and to the bone.

Inion FreedomScrew™ Instruments 2/2

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Inion FreedomScrew™ 4.5 mm Inion OTPS™ Screw 4.5 mm

Maximum Shear Load Capacity (N) Measured after 24 hours in 37oC

Inion FreedomScrew™ Features 1/9

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Inion FreedomScrew™ 2.7 mm Inion OTPS™ Screw 2.8 mm

Max pull-out load capacity (N) Measured after 24 hours in 37oC

Tested with sawbones (failure mechanism = sawbones)

Improved pull-out strength also in less dense bone.


Full compatibility with generic O&T Instrumentation

Inion FreedomScrewTM is compatible with most of the universal instrumentation used in hospitals around the world: ISO, ASIF, AO

Universal disposable metallic adapter

Universal tap/screw profile


Inion FreedomScrewTM (LAG) provides: High fixation strength

Compression to fracture line

No material creeping within healing period, compression will be maintained

Due to the thread profile, screw bites in the walls of the drilled/tapped screw hole


Inion FreedomScrewTM can be cut into specific lengths after the insertion:

When Inion FreedomScrewTM is cut by temperature cautery it will automatically generate a new screw head to the screw shaft. This phenomenal feature is inherent to polymer structure generated during the Inion FreedomScrewTM manufacturing process.

With scissors With temperature cautery


Features Creating a new screw head with Temperature Cautery:

Use Heat – Not Force!


Creating a low profile plate fixation with Temperature Cautery:

Cut Inion FreedomScrewTM about 1-2 mm above the plate surface and heat will generate a new screw head and locking effect to the plate.


Resorbable Locking Plate When used with Inion FreedomPlateTM, screw can be inserted into the plate in different places at multible insertion angles, and locked to the plate.

Always optimal fixation!

Inion Freedom™ Features 8/9

Multiple variations for multiple indications:

Modified plate/screw combination creates a 3D fixation device with strong anatomical fit.

Inion Freedom™ Features 9/9

Operational technique Inion Freedom™

Open the sterile drape peel pouch and unfold the sterile drape onto a sterile table.

The scrub nurse places both hands inside the sterile drape pouch while the circulating assistant inserts the water bath against the drape’s closed end.

The sterile drape pouch is turned inside out. The opening of the sterile pouch remains around the power cable.

Water bath set-up instructions (1/3)

The water bath is now ready to be placed on a sterile table close to the operating surgeon.

After placing the draped water bath on the sterile table, make a depression into which sterlile water or saline can be poured. Ensure that the drape lines the bottom of the water bath and that no air is left between the drape and the water bath basin. This is important to ensure correct temperature of the sterlie fluid during procedure.

Note! Use Inion Thermo + water bath with Inion FreedomPlate™ (T: 70°C / 158°F).

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Pour sterile water or saline into the bath. Fill the bath just over half full (ca. 0.5l). Remember to ensure that this amount of fluid is in the bath during the procedure. Once more ensure there is no air between the bath and the sterile drape.

Once fluid is in the bath, plug the cable in.

The water bath can now be switched on.

Note! Heating of the water takes ~30minutes.

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After preconditioning in Inion Thermo+TM waterbath for 1 minute, the plate is malleable for approximately 10 seconds.

Mold the plate along the anatomy and shape with scissors, if needed.

Water bath treatment can be repeated up to three times, if additional contouring is required (for max. 30 minutes).

Plate customization

A - Traditional technique (screw with a head, similar to metallic screws) B - Screw cutting after the insertion (using temperature cautery or cutting pliers)

C - Use with Inion FreedomPlate™

Summary of operation techniques Inion FreedomScrew ™ (A, B, C)

A - Traditional technique (screw with a head, similar to metallic screws)

A1. Select an appropriate screw diameter for indication A2. Drill a screw channel through the fracture/osteotomy line using appropriate drill or drill

tap size A3. When applicable, tap the screw channel manually

with appropriate tap. Use irrigation! - Note the difference between the bone qualities; osteoporotic vs. hard bone A4. If needed, countersink a space for the screw head

A5. Measure the depth of the screw channel and cut the screw to the correct length with screw cutting pliers

A6. Use irrigation to flush out the bone debris A7. Insert the screw fully into the screw channel using appropriate screwdriver - Note! In case the friction rises too much during insertion, screw must be removed and the screw channel must be rinsed and/or re-tapped A8. Remove the disposable metallic insertion adapter from the screw with the screwdriver


B - Screw cutting after the insertion (using temperature cautery or cutting pliers)

B1. Insert the screw into the drilled/tapped screw channel without countersinking

B2. Measure the depth of the screw hole with a depth gauge or a drill tap or bone tap with depth markings

B3. Mark the depth on the screw shaft

B4. Insert the screw up to the marked depth and cut with regular cutting pliers or with temperature cautery

B5. Cut the screw 1-2 mm above the bone surface with low temperature cautery letting the heat reform a smooth new screw head while cutting

B5. Optional: Cutting with regular cutting pliers: Cut the screw along the bone surface trying to avoid protruding sharp corners which could cause soft tissue irritation

Cutting with temperature cautery is recommended because heat is generating a new smooth surface on the screw head (Inion FreedomScrew™ expands from its shaft because of the memory effect created during the manufacturing) and enables even more stable and secured fixation.


B - Using one long screw as two short screws After on insertion technique B, remaining screw can be sharpened with screw cutting pliers and re-inserted into a new screw channel.

B2. Sharpen the distal end of the remaining screw with screw cutting pliers B3. Prepare a new screw channel according to the previously instructed steps (drill + tap, or drill tap) and insert the sharpened screw to the channel


C - Use with Inion FreedomPlate™

C1. Modify the Inion FreedomPlate™ according to instructions and select appropriate screw diameter for the indication C2-C3. Drill and tap, or use the drill tap to create a screw channel through the Inion FreedomPlate™

into the bone (and fracture line if needed) using appropriate drill size C4. Use irrigation to flush out the bone debris C5. The depth of the screw hole is measured and marked on the screw. C6. Insert the screw to the marked depth using appropriate screwdriver C7. Cut the screw 1-2mm above the plate surface with temperature cautery, allowing the temperature to create a smooth screw head above the plate and lock screw to the plate


Set up the water bath before the operation begins

Reduce fracture

Precondition the plate

Customize of the plate (cutting, shaping, contouring)

Fasten the plate:

Create the drill hole with a drill or drill tap

Measure the drill hole depth

When applicable, tap the screw hole

Insert the screw

Customize the screw by removing the screw head

Ensure the patient has appropriate postoperative instructions

Summary of operation technique steps with Inion FreedomPlate ™

Select appropriate Inion Freedom™ screw(s) for the indication.

Use the Drill sleeve with the Drill tap. Press the instruments firmly against the bone. Drill through the fracture/osteotomy line using slow speed on a slow-speed drill, which has a reverse function. Use irrigation.

Follow the depth markings on the Drill tap shaft to determine the correct screw length. Use intraoperative X-ray to confirm the location of the Drill tap. Set the power drill to reverse when removing the Drill tap from the bone.

Alternatively, use the depth gauge to confirm the needed screw length.

Mark the required screw length on the screw shaft with a sterile marker (measured from the tip of the screw).

Surgical technique with the Drill tap 1/2

Insert the screw into the drill hole using appropriate screwdriver until the mark reaches the bone surface.

Cut and trim the screw using a Low temperature cautery instrument 1–2 mm above the bone surface.

Surgical technique with the Drill tap 2/2

Fixation of Inion FreedomPlateTM with the Drill tap Select appropriate Inion Freedom™ implant(s) for the indication. Use the Drill sleeve instrument with the Drill tap. Press the plate tightly

against the bone to allow proper plate-bone contact. Drill through the plate using slow speed on a slow-speed drill. Use irrigation. Set the drill machine to reverse when removing the Drill tap from the bone. Determine and mark the required screw length on the screw shaft as

described above. Insert the screw until the mark reaches the plate surface. Cut, trim, and lock the screw to the plate using a Low temperature cautery

instrument 1–2 mm above the plate surface.

Appropriate, additional immobilisation (e.g. a plaster cast) should be used during bone healing.

Immobilisation and weight bearing schedules are always based on the indication and surgeons consideration

One example of the immobilisation times with bimalleolar ankle fracture:

Weeks 0-3 no loading

Weeks 3-5 partial weight bearing

Weeks 5-6 loading within pain tolerance

Full load bearing is allowed only after fracture/osteotomy healing has been confirmed

Postoperative management

Considerations for optimal fixation 1/2

Make the plate shape and size optimal for the surgical site. When cutting the plate, do not cut too close to the pilot holes intended to be used for screw insertion. Trim all sharp edges before implantation.

Use irrigation during drilling to prevent enlarging the plate hole due to the heat.

Use the pilot holes in the plate for optimal fixation. Additional holes can also be drilled between the pilot holes if needed.

When drilling and tapping through the plate, press the plate tightly against the bone to ensure proper plate-bone contact for optimal fixation.

Always insert screws through the pilot holes closest to the fracture/osteotomy line. However, the minimal distance to the fracture/osteotomy line must be equal to the diameter of the screw shaft.

Insert at least 4 screws on both sides of the fracture line (recommendation).

Considerations for optimal fixation 2/2

Insert the screws bicortically for optimal fixation. Insert the screws at different angles for improved biomechanical

stability. Place one of the screws across the fracture line (when applicable) to

increase fixation strength of the plate-screw construct. Place screws close to the edges of the plate to ensure that the plate

edges remain tightly against the bone to allow three-dimensional locking.

Cut the screw heads off (of fully threaded screws) and lock the screws to the plate by using a temperature cautery. Cutting the screw heads off interlocks the screws to the plate, as well as reduces the construct profile and the risk of soft tissue irritation.

Use depth gauges and radiographic imaging (utilizing K-wires and/or drill taps and bone taps with depth markings) intraoperatively to ensure correct length and placement of the screw(s).

Clinical considerations

Comparison of costs in ankle fractures treated with absorbable or metallic fixation devices Arch Orthop Trauma Surg. 1997;116(4):204-8.

Bostman O et al. 1991.

.

In bimalleolar fractures, the coefficient was 1.04 (cost of absorbable fixation 4% higher than that of metallic fixation) if the removal percentage with metallic fixation was zero and 0.91 (cost of absorbable fixation 9% lower than that of metallic fixation) if the removal percentage was 100%. If removal is required, it can cost between $2,533 and $11,710 or more, according to Saint Elizabeth Regional Medical Center in Lincoln, Nebraska

→Total cost of metal plate fixation is 29 % higher than absorbable plate

Complication rate of the metal implants by removal surgery Injury. 1992;23(1):29-30.

188 patients, an overall 20 per cent complication rate

Highest complication rate: 42 per cent with forearm fractures

Infection was the most common complication, and was particularly high in those fractures which were originally open (43 per cent) and where infection developed after the initial internal fixation (32 per cent).

Ann Plast Surg. 2005 Dec;55(6):608-11.

135 patients with titanium plate fixation for traumatic facial fractures

Overall, 33.3% (45/135) removed;

64.4% (29/45) for complications, ie, discomfort, exposure, and infection;

The most common complication was discomfort related to palpability, cold

intolerance, and pain. This constituted 72.4% (21/29) of all plate removals for

complications.

Metal vs. biodegradable plate removals

Per Aspenberg , Bone: Silk, metal and bone: why take implants out?, 2014, Nature Reviews. Rheumatology, (10), 7, 386-387.

Implant removal is surprisingly common. In Sweden, 37,000 adult patients received metal fracture fixation implants in 2011, and 13,000 underwent implant removal.

The number of adults undergoing fracture surgery in Sweden increased from 2005 to 2011 by 20 %, but removals increased by 35 %. The highest rate of removal (70%) was reported for the ankle and foot.

Kukk et al 2009, A retrospective follow-up of ankle fracture patients treated with a biodegradable plate and screws, Foot and Ankle Surgery

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8,0 0,0

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100,0

Metal Biodegradable

Clinical results

• Hardware removal 34% in the metal group 0% in the biodegradable group after average follow-up of 20 months

Clinical results

Metal allergy

Incidence

Contact allergy to metals such as nickel, cobalt, and chromium is prevalent in the general population.

It is estimated that up to 17% of women and 3% of men are nickel allergic, and that about 1 to 2% are allergic to cobalt, chromium, or both.

fibromyalgia

hives

joint pain

muscle pain

rash

reddening of skin

swelling

Common symptoms of metal hypersensitivity include:

blistering of the skin

chronic fatigue

chronic inflammation

cognitive impairment

depression

Common metal allergy symptoms

Feature Benefit Fully customisable plating system Always a custom plate

Can be used even in the most challenging anatomies

Plates can be cut to required shape and size

Screws are trimmed to length

Low inventory quantities (one plate + one screw code)

Low profile construct Low risk of tissue irritation/reaction

Variable screw angulation (polyaxial screws) Screw position and direction can be determined based on the anatomy always optimal fixation

Screws interlock with the plate Lower risk of screw back-out

Low profile construct (allows screw head removal)

Flexible placement of screws Screw position and direction can be determined based on the anatomy

Transparent and radiolucent Enables full visualisation of the fracture/osteotomy site both during the operation and postoperatively

Drill taps Enables one step drilling and tapping saving insertion time

Biodegradable Avoidance of hardware removal

Features and benefits of Inion Freedom™

Documents

Inion Freedom™ Resorbable Fixation System · Inion FreedomScrew™ - Fully threaded Art. No. Description . OSA-2010 FreedomScrew 2.0 x 10 mm . OSA-2012 FreedomScrew 2.0 x 12 mm