Inion Freedom™ Resorbable Fixation System
Version 5, 01/2020 & Clinical considerations
Inion Freedom Resorbable Fixation System Version 5, 01/2020 & - - PowerPoint PPT Presentation
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:
Version 5, 01/2020 & Clinical considerations
Inion Freedom™ is composed of: Inion FreedomScrew™ and Inion FreedomPlate™ “One screw and one plate” ideology offers:
anatomies and fixation screws which interlock with the plate)
Product Message: Strong and effective fixation system to several different Orthopaedic & Trauma indications.
Inion FreedomPlate™ Maintenance of aligment and fixation of
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:
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:
cancellous bone fractures, osteotomies or arthrodesis of the upper extremity, ankle and foot in the presence of appropriate brace and/or immobilization
ankle fractures
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
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
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
Description OSC-4090 FreedomScrew 4.0 x 90 mm, Cannulated
Inion FreedomScrew™ - Fully threaded
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
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™ - Partially threaded (LAG)
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
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
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™ Drill Taps and Bone taps:
Drill tap - Drill and tap combined:
with one instrument
Bone tap Use of the Bone taps and Drill taps:
used with the Drill sleeve instrument
at 5 mm increments, when used with the Drill sleeve
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.
100 200 300 400 500 600 700 800 900 1000 Inion FreedomScrew™ 4.5 mm Inion OTPS™ Screw 4.5 mm
Measured after 24 hours in 37oC
20 40 60 80 100 120 140 160 180 Inion FreedomScrew™ 2.7 mm Inion OTPS™ Screw 2.8 mm
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:
healing period, compression will be maintained
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
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!
Multiple variations for multiple indications: Modified plate/screw combination creates a 3D fixation device with strong anatomical fit.
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
power cable.
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).
6 6
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.
7
7
9
9
is malleable for approximately 10 seconds.
contouring is required (for max. 30 minutes).
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™
A - Traditional technique
(screw with a head, similar to metallic screws)
fracture/osteotomy line using appropriate drill or drill tap size
with appropriate tap. Use irrigation!
the screw to the correct length with screw cutting pliers
appropriate screwdriver
insertion, screw must be removed and the screw channel must be rinsed and/or re-tapped
from the screw with the screwdriver
B - Screw cutting after the insertion
(using temperature cautery or cutting pliers)
without countersinking
regular cutting pliers or with temperature cautery
temperature cautery letting the heat reform a smooth new screw head while cutting
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.
+ tap, or drill tap) and insert the sharpened screw to the channel
C - Use with Inion FreedomPlate™
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
temperature to create a smooth screw head above the plate and lock screw to the plate
indication.
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.
determine the correct screw length. Use intraoperative X-ray to confirm the location of the Drill
Drill tap from the bone.
needed screw length.
with a sterile marker (measured from the tip of the screw).
appropriate screwdriver until the mark reaches the bone surface.
temperature cautery instrument 1–2 mm above the bone surface.
Fixation of Inion FreedomPlateTM with the Drill tap
against the bone to allow proper plate-bone contact.
described above.
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
fracture:
been confirmed
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.
the heat.
can also be drilled between the pilot holes if needed.
against the bone to ensure proper plate-bone contact for optimal fixation.
fracture/osteotomy line. However, the minimal distance to the fracture/osteotomy line must be equal to the diameter of the screw shaft.
(recommendation).
stability.
increase fixation strength of the plate-screw construct.
edges remain tightly against the bone to allow three-dimensional locking.
to the plate by using a temperature cautery. Cutting the screw heads
profile and the risk of soft tissue irritation.
drill taps and bone taps with depth markings) intraoperatively to ensure correct length and placement of the screw(s).
.
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
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.
Per Aspenberg , Bone: Silk, metal and bone: why take implants out?, 2014, Nature
fracture fixation implants in 2011, and 13,000 underwent implant removal.
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
35,1 8,0 0,0 20,0 40,0 60,0 80,0 100,0 Metal Biodegradable
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.
hypersensitivity include:
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