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:  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

Where? – Indications 2/3 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

Where? – Indications 3/3 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™ Inion FreedomScrew™ - Fully threaded Inion FreedomScrew™ - Fully threaded, Cannulated - Art. No. Description Syndesmosis Screw OSA-2014 FreedomScrew 2.0 x 14 mm Art. No. Description OSA-2020 FreedomScrew 2.0 x 20 mm OSC-4090 FreedomScrew 4.0 x 90 mm, Cannulated 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 Inion FreedomScrew™ - Partially threaded (LAG), Cannulated OSA-4540 FreedomScrew 4.5 x 40 mm Art. No. Description OSA-4555 FreedomScrew 4.5 x 55 mm OSD-3530 FreedomScrew 3.5 x 30 mm (LAG) , Cannulated OSD-3535 FreedomScrew 3.5 x 35 mm (LAG), Cannulated Inion FreedomScrew™ - Fully threaded, Cannulated OSD-3540 FreedomScrew 3.5 x 40 mm (LAG), Cannulated OSC-3530 FreedomScrew 3.5 x 30 mm, Cannulated OSD-3545 FreedomScrew 3.5 x 45 mm (LAG), Cannulated OSC-3545 FreedomScrew 3.5 x 45 mm, Cannulated OSD-4535 FreedomScrew 4.5 x 35 mm (LAG), Cannulated OSC-4540 FreedomScrew 4.5 x 40 mm, Cannulated OSD-4540 FreedomScrew 4.5 x 40 mm (LAG), Cannulated OSC-4555 FreedomScrew 4.5 x 55 mm, 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™ (C-categorized products) Inion FreedomScrew™ - Fully threaded Inion FreedomScrew™ - Fully threaded, Cannulated - Art. No. Description Syndesmosis Screw OSA-2010 FreedomScrew 2.0 x 10 mm Art. No. Description OSA-2012 FreedomScrew 2.0 x 12 mm OSC-3520 FreedomScrew 3.5 x 20 mm, cannul. OSA-2016 FreedomScrew 2.0 x 16 mm OSC-3525 FreedomScrew 3.5 x 25 mm, cannul. OSA-2018 FreedomScrew 2.0 x 18 mm OSC-3535 FreedomScrew 3.5 x 35 mm, cannul. OSA-2712 FreedomScrew 2.7 x 12 mm OSC-3540 FreedomScrew 3.5 x 40 mm, cannul. OSA-2714 FreedomScrew 2.7 x 14 mm OSC-4535 FreedomScrew 4.5 x 35 mm, cannul. OSA-2718 FreedomScrew 2.7 x 18 mm OSC-4545 FreedomScrew 4.5 x 45 mm, cannul. OSA-2720 FreedomScrew 2.7 x 20 mm OSC-4550 FreedomScrew 4.5 x 50 mm, cannul. OSA-2725 FreedomScrew 2.7 x 25 mm OSC-4590 FreedomScrew 4.5 x 90 mm, cannul. OSA-2730 FreedomScrew 2.7 x 30 mm OSA-2735 FreedomScrew 2.7 x 35 mm Inion FreedomScrew™ - Partially threaded (LAG) OSA-3520 FreedomScrew 3.5 x 20 mm Art. No. Description OSA-3525 FreedomScrew 3.5 x 25 mm OSB-3520 FreedomScrew 3.5 x 20 mm (LAG) OSA-3535 FreedomScrew 3.5 x 35 mm OSB-3525 FreedomScrew 3.5 x 25 mm (LAG) OSA-3540 FreedomScrew 3.5 x 40 mm OSB-3530 FreedomScrew 3.5 x 30 mm (LAG) OSA-4535 FreedomScrew 4.5 x 35 mm OSB-3535 FreedomScrew 3.5 x 35 mm (LAG) OSA-4545 FreedomScrew 4.5 x 45 mm OSB-3540 FreedomScrew 3.5 x 40 mm (LAG) OSA-4550 FreedomScrew 4.5 x 50 mm OSB-3545 FreedomScrew 3.5 x 45 mm (LAG) OSA-4590 FreedomScrew 4.5 x 90 mm OSB-4535 FreedomScrew 4.5 x 35 mm (LAG) OSB-4540 FreedomScrew 4.5 x 40 mm (LAG) Inion FreedomScrew™ - Partially threaded (LAG), OSB-4545 FreedomScrew 4.5 x 45 mm (LAG) Cannulated OSB-4550 FreedomScrew 4.5 x 50 mm (LAG) Art. No. Description OSB-4555 FreedomScrew 4.5 x 55 mm (LAG) OSD-3520 FreedomScrew 3.5 x 20 mm (LAG), cannul. OSD-3525 FreedomScrew 3.5 x 25 mm (LAG), cannul.

Inion FreedomScrew™ Instruments 1/2 IFS-2001 Drill bit Ø1.5 mm IFS-9042 Depth gauge for Ø2.7 - 4.5 mm screws ,with K-wire IFS-2002 Tap Ø2.0 mm IFS-9043 K-wire Ø1.6 mm (used with depth gauge) IFS-2006 Drill tap Ø2.0 mm IFS-9051 Screw cutting pliers IFS-2701 Drill bit Ø2.0 mm IFS-9052 Scale for Ø2.0/2.7 mm screws IFS-2702 Tap Ø2.7 mm IFS-9053 Scale for Ø3.5 - 4.5 mm screws IFS-2706 Drill tap Ø2.7 mm INS-9093 Small handle, cannulated (set contains two pieces IFS-3501 Drill bit Ø2.5 mm of INS-9093) IFS-3502 Tap Ø3.5 mm INS-9120 Large handle, cannulated IFS-3503 Drill bit Ø2.7 mm, cannulated IFS-9801 Instrument tray IFS-3504 Tap Ø3.5 mm, cannulated IFS-9901 FULL - FreedomScrew Instrument set IFS-3506 Drill tap Ø3.5 mm with tray IFS-3508 Drill tap Ø3.5 mm, cannulated IFS-4004 Tap Ø4.0 mm, cannulated HTC-0000 Low Temperature Cautery (10 pcs.) IFS-4008 Drill tap Ø4.0 mm, cannulated ACC-9802 Inion Thermo drape (5 drapes) IFS-4501 Drill bit Ø3.2 mm ACC-9810 Inion Thermo+ water bath (230 V+EU plug) IFS-4502 Tap Ø4.5 mm ACC-9840 Inion Thermo+ water bath (110V+US plug) IFS-4503 Drill bit Ø3.2 mm, cannulated IFS-9061 K-wire Ø1.25 mm (10 pieces) IFS-4504 Tap Ø4.5 mm, cannulated IFS-9062 K-wire Ø1.6 mm (10 pieces) 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

Inion FreedomScrew™ Instruments 2/2 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™ Features 1/9 Maximum Shear Load Capacity (N) Measured after 24 hours in 37 o C 1000 900 800 700 600 500 400 300 200 100 0 Inion FreedomScrew™ 4.5 mm Inion OTPS™ Screw 4.5 mm

Inion FreedomScrew™ Features 2/9 Max pull-out load capacity (N) Measured after 24 hours in 37 o C 180 160 140 120 100 80 60 40 20 0 Inion FreedomScrew™ 2.7 mm Inion OTPS™ Screw 2.8 mm Tested with sawbones (failure mechanism = sawbones)  Improved pull-out strength also in less dense bone.

Inion FreedomScrew™ Features 3/9 Full compatibility with generic O&T Instrumentation Universal disposable Universal tap/screw profile metallic adapter Inion FreedomScrew TM is compatible with most of the universal instrumentation used in hospitals around the world: ISO, ASIF, AO

Inion FreedomScrew™ Features 4/9 Inion FreedomScrew TM (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