Inion FixOn™ BioComposite Suture Anchor Training presentation Version: 2019-04 Inion FixOn™ BioComposite Suture Anchor Sizes: Ø 4.5 mm, Ø 5.5 mm and Ø 6.5 mm With two or three preloaded high strength sutures Inion FixOn™ Biocomposite Suture Anchor Shoulder anatomy Inion FixOn™ Biocomposite Suture Anchor Shoulder anatomy Rotator cuff Glenoid Scapula Labrum Inion FixOn™ Biocomposite Suture Anchor Indications . Indications . Soft tissue fixation to bone . Designed especially for rotator cuff repair in shoulder Inion FixOn™ Biocomposite Suture Anchor Indications Inion FixOn™ Acromion Supraspinatus Tendon of supraspinatus Subscapularis Biceps tendon Tendon of subscapularis Biceps muscle Scapula Inion FixOn™ Biocomposite Suture Anchor Advantages . The only colored bioabsorbable suture anchor in the market . High fixation strength . Double threaded in cortical bone . The most safe biocomposite based on the clinical literature . Similar composition to DePuy/Synthes/Mitek Inion FixOn™ Biocomposite Suture Anchor Designing philosophy . Optimal degradation time 2-3 years . Osteoconductive material TCP filler . Easy to see in arthroscopic procedure Colored anchor . High strength composite material Fine particle TCP . High fixation strength Dual thread in cortical bone area . Material composition 85/15 PLGA + 30% β-TCP + < 0.03 wt% D&C Green 6 color Inion FixOn™ Biocomposite Suture Anchor Product portfolio – Suture anchors Ø 6.5 mm anchors Ø 5.5 mm anchors Ø 4.5 mm anchors 2 or 3 sutures preloaded Inion FixOn™ Biocomposite Suture Anchor Product portfolio – Suture anchors Article Description number FOB-4502 4.5mm INION FixOn™ Biocomposite Suture Anchor with two (2) Suprabraid™ sutures (#2, metric 5) FOB-4503 4.5mm INION FixOn™ Biocomposite Suture Anchor with three (3) Suprabraid™ sutures (#2, metric 5) FOB-5502 5.5mm INION FixOn™ Biocomposite Suture Anchor with two (2) Suprabraid™ sutures (#2, metric 5) FOB-5503 5.5mm INION FixOn™ Biocomposite Suture Anchor with three (3) Suprabraid™ sutures (#2, metric 5) FOB-6502 6.5mm INION FixOn™ Biocomposite Suture Anchor with two (2) Suprabraid™ sutures (#2, metric 5) FOB-6503 6.5mm INION FixOn™ Biocomposite Suture Anchor with three (3) Suprabraid™ sutures (#2, metric 5) Sutures: Blue: UHMWPE with colorant Chromium-Cobalt-Aluminium Oxide, nonabsorbable White/Blue: Cobraid of UHMWPE and blue polypropylene, nonabsorbable White/Black: Cobraid of UHMWPE and black nylon, nonabsorbable White: UHMWPE (Ultra-high molecular weight polyethylene), nonabsorbable Inion Suprabraid™ Suture Reference: Product brochure, ForceFiber® Sutures and Braids, 2017, Teleflex Medical OEM Inion FixOn™ Biocomposite Suture Anchor Product portfolio – Instruments Article number: Description INS-9630 Reusable tap for 4.5 mm Biocomposite Suture Anchors INS-9631 Reusable tap for 5.5 mm Biocomposite Suture Anchors INS-9632 Reusable tap for 6.5 mm Biocomposite Suture Anchors INS-9633 Reusable awl for 4.5 mm Biocomposite Suture Anchors INS-9634 Reusable awl for 5.5/6.5 mm Biocomposite Suture Anchors Inion FixOn™ Instruments are placed in the second layer (INS-9640) of the Inion® Shoulder instrument tray (INS-9619) Inion FixOn™ Biocomposite Suture Anchor Product portfolio – Instruments Inion® Shoulder Instrument Set Inion® Shoulder instrument set and tray INS-9620 Inion® Shoulder instrument tray INS-9640 (for Inion FixOn™ anchors) Inion FixOn™ Biocomposite Suture Anchor Product portfolio – Instruments Inion® Shoulder Instrument Set Inion FixOn™ Instruments Article number: Description INS-9630 Reusable tap for 4.5 mm Biocomposite Suture Anchors INS-9631 Reusable tap for 5.5 mm Biocomposite Suture Anchors INS-9632 Reusable tap for 6.5 mm Biocomposite Suture Anchors INS-9633 Reusable awl for 4.5 mm Biocomposite Suture Anchors INS-9634 Reusable awl for 5.5/6.5 mm Biocomposite Suture Anchors 2nd level tray (INS-9640 can be accommodated in INS-9619 INS-9640 Inion® Shoulder instrument tray) Inion FixOn™ Biocomposite Suture Anchor Competitive suture anchors . Inion FixOn™ Biocomposite suture anchor . DePuy/Synthes/Mitek – Healix Advance BR . Conmed Linvatec – Cross FT BC . Arthrex Corkscrew . Smith&Nephew Twinfix HA Inion FixOn™ Biocomposite Suture Anchor Fixation strength of the competitive suture anchors Fixation strength (pull-out) in Newtons 5.5mm Healix 4.5mm Healix . Tested in 10 pcf Sawbones foam, pull-out speed 4.23 mm/s . Reference: Data on file at DePuy Mitek Inc., Raynham, MA. August 2012 (https://www.depuysynthes.com/hcp/mitek-sports-medicine/products/qs/HEALIX- ADVANCE#tab2) Inion FixOn™ Biocomposite Suture Anchor Fixation strength comparison to competitive product Inion FixOn™ Biocomposite Suture Anchor Fixation strength comparison to competitive product Pull-out strength of 4.5 mm from 12 pcf Sawbones foam Inion FixOn™ Biocomposite Suture Anchor Biodegradadion of the PLGA/β-TCP composite in vivo . DePuy/Mitek data* PLGA/β-TCP composite Inion FixOn™ suture anchors . Complete bioabsorption of polymer component in 24-36 months based on in-vitro hydrolysis data. *Reference: https://www.depuysynthes.com/hcp/knee/products/qs/BIOCRYL-RAPIDE- Biocomposite-Material Inion FixOn™ Biocomposite Suture Anchor Bioabsorption in-vitro Inion FixOn™ Biocomposite Suture Anchor Drivers Driver tips Inion FixOn™ Biocomposite Suture Anchor Suprabraid™ Sutures UHMWPE #2 Sutures (Ultra-high molecular weight polyethylene) Non-absorbable Blue Blue stripe Black stripe White Blue: UHMWPE with colorant Chromium-Cobalt-Aluminium Oxide White/Blue: Cobraid of UHMWPE and blue polypropylene White/Black: Cobraid of UHMWPE and black nylon White: UHMWPE Inion FixOn™ Biocomposite Suture Anchor Screw driver tip and handle . Sutures go around the eyelet of the anchor and inside the cannulated driver . Sutures are coiled in the handle Inion FixOn™ Biocomposite Suture Anchor Suture anchor design 4.5 mm 5.5 mm 6.5 mm Eyelet bar Sutures go around the eyelet bar Cross section of the anchors Double thread In cortical bone section Inion FixOn™ Biocomposite Suture Anchor Sales arguments . Inion FixOn™ Biocomposite Suture Anchor . is made of osteoconductive material . osteoconductive material (PLGA + β-TCP) enhances biocompatibility (Perianchor Cyst Formation Around Biocomposite Biodegradable Suture Anchors After Rotator Cuff Repair, Kim Sae Hoon et. al., The American Journal Sports Medicine, Volume 43, Issue 12, 2015.) . degrades between 2 to 3 years . has excellent fixation strength . restores natural anatomy . has double threading for cortical layer . has 6 heavy duty threads (3 cortical + 3 cancellous) . has latest generation UHMWPE suture . strong and durable . lubricious -> easy to knot and handle Inion FixOnTM Ti suture anchor Surgical technique Rotator cuff repair Notice: Same technique is applied for all Inion FixOnTM Suture anchors in rotator cuff repair Tip: how to release sutures from the driver handle? . Release the sutures from the driver handle and untangle them by pulling sutures straight with fingers. Tip: how to release sutures in case they get stuck in the driver cannula? . In case the sutures get stuck in the driver cannula when removing the driver from the bone after anchor insertion, pull them carefully one by one from the tip of the driver shaft. Post Operative Reminders . As with any surgical procedure, careful postoperative management is important for optimal healing . Provide the patient with detailed instructions for postoperative care . Use appropriate additional immobilization . Provide antibiotic therapy at the discretion of the clinician . Inion FixOn™ Biocomposite Suture Anchor is MR Safe .