INSITE FT. Small-Bone Anchors. Achilles TENSIONBRIDGE with Cinchable 3.5mm PITON
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1 INSITE FT Small-Bone Anchors Biocomposite PEEK-OPTIMA Titanium Achilles TENSIONBRIDGE with Cinchable 3.5mm PITON O.R. Efficiency driven by: Easy-to-remove needles housed in the top of the inserter handle Size-specific implants and instruments designed specifically for smallbone anatomy and open surgical procedures Zero potential for silicone-induced foreign body granulomas or sterile abscesses The unique handling properties of FORCE FIBER are derived from it s proprietary all-braided design rather than from a silicone coating Optimal tendon footprint compression when paired with the cinchable knotless 3.5 PITON
2 The Achilles TENSIONBRIDGE Optimal tendon footprint compression The Achilles TENSIONBRIDGE is the only system that provides optimal tendon footprint compression by allowing the surgeon to independently tension the suture tails after the cinchable knotless 3.5 PITON is deployed. Proximal row of INSITE FT Small Bone Anchors are available: In titanium, PEEK, or biocomposite to accommodate surgeon preferences and patient biology In 4.5 & 5.5mm diameters for strong fixation Pre-loaded with two strands of size #2 braided high-tensile strength FORCE FIBER suture Insert INSITE FT implants into prepared bone holes After securing tissue and BIOFIBER proximally, prepare distal bone holes for 3.5 PITONS using 3.5 mm bit BIOFIBER discs and strips: Reinforce the suture tendon interface the weak link in tendon repairs making the construct 73% stronger than without reinforcement Load one suture tail from each proximal anchor into a 3.5 PITON using nitinol snare, insert 3.5 PITON into bone, and deploy per the IFU Cycle suture tails independently to initiate footprint compression Effect of BIOFIBER Scaffold on Suture Pullout Strength in a Tendon Model. WhitePaper CAW Distal row of 3.5 mm cinchable knotless PITON anchors: Allow the surgeon to independently tension the suture tails after anchor deployment, due to the cinch ring locking mechanism similar to a football belt buckle Repeat for second 3.5 PITON to set preliminary footprint compression When desired/optimal compression is attained, cut tails to bone surface
3 Improved O.R. Efficiency with easy-off needles housed in the back of the inserter handle Easy needle removal saves me valuable O.R. time by reducing fiddle factor. James Sferra, MD Cleveland, OH Zero chance of silicone-induced foreign body granulomas, sterile abscesses, or sinus tracts associated with competitive silicone-coated high strength sutures Proprietary braid produces silky smooth feel FORCE FIBER is composed of 1% ultra-high molecular weight polyethylene (UHMWPE) that is incredibly strong and durable. Built with a proprietary braid construction, FORCE FIBER exhibits a flexibility and pliability that makes it easy to work with in the operating room. It is nonabrasive and has a silk-like feel that is gentle on tissue and gloves. The silky feel is attributable to the unique proprietary braid, eliminating the need for a silicone coating. Silicone-induced foreign-body reactions in the literature: five patients whose amputations had been performed by four different surgeons presented to the amputation clinic at a mean of 9.1 months (range, five to eleven months) postoperatively with similar sinus tracts through otherwise well-healed incisions. In all five patients, the suture used to secure the myodesis was Fiberwire [following excision and analysis] this analysis confirmed the presence of silicone granulomas in the excised tissue surrounding the Fiberwire suture. Ticron is the only other high tensile-strength synthetic suture sold in the United States that has a silicone coating. Warme et al reported a late (3.5-year postoperative) foreign-body reaction after the use of Ticron to secure an inferior capsular shift. At surgery, two displaced Ticron sutures had migrated superficial to the subscapularis where they were found in a sterile seroma. Mack AW, et al. Wound Complications Following the Use of Fiberwire in Lower-Extremity Traumatic Amputations. JBJS 29; 91:68-5. Warme WJ, Burroughs RF, Ferguson T. Late Foreign-body Reaction to Ticron Sutures Following Inferior Capsular Shift: A Case Report. Am J Sports Med. 24; 32:232-6.
4 Surgical Overview Brostrom and Kidner Procedures Brostrom Surgical Overview Drill pilot holes using guide wire packaged with 3.5 mm INSITE FT Kidner Surgical Overview Insert two 3.5 mm INSITE FT anchors into the distal fibula Pass all 8 suture tails through the ATFL moving from posterior to anterior and tie down to complete the repair After detaching the PTT, remove accessory navicular using a chisel or saw Prepare bone hole in navicular using a punch or punch-tap as dictated by density of the bone Insert anchor into prepared bone hole and pass the needled suture through the PTT to secure it back to the navicular Superior Biomechanics 85 Superior Anchor Load-to-Failure 16% Stronger 4 Superior Suture Knot Strength Knot Tensile Load-to-Failure (lbf) Biocomposite INSITE FT Arthrex Biocomposite Corksrew FT Average Load (lbs) mm FORCE FIBER Fiberwire ORTHOCORD ETHIBOND Data on file in 51(k) submission Data on file at Teleflex, Inc.
5 Mid-Substance Achilles Repair with PHANTOM FIBER PHANTOM FIBER High Strength, Resorbable Suture Proven Strong, Then It s Gone. Braided high tensile strength suture Full resorption at months Eliminates long-term problems associated with permanent sutures such as skin abrasion superficial to the surgical site Retains 5% of its Strength at 12 Weeks Resorption of PHANTOM FIBER Suture 171 Full Resorption at Months Strength (N) Breaks Down Into Water and Carbon Dioxide Poly-4-Hydroxybutyrate (P4HB) Hydrolysis * 26* Time (weeks) CO2 * Time points measured with a 12 carrier braid suture. Data on file. Study was performed in vivo. CONEXA Reinforced Achilles Repairs are 64% Stronger than Suture Alone Load-to-Failure CONEXA is the first orthopedic Extra Cellular Matrix (ECM) to feature: 5 S terility: Compared to non-sterile human tissues 4 Supports tissue regeneration Load (N) Pre-hydration: Saving OR time R oom temperature storage: for convenient facility handling Posterior Reinforcement 3 No Reinforcement 2 1 Failure Posterior Mechanical Reinforcement of a Standard Krackow Achilles Tendon Repair Using a New Xenograft Matrix W. Corey, MD, L. Hermida, MD, B.G. Parks, MS, and L. Schon, MD. Tornier Whitepaper BAW-738 REV: A H2O
6 OR efficiency from: Shorter instruments tailored to open surgical procedures Arthroscopic Length Mini-Open Length And implants designed specifically for small-bone anatomy Ordering Information Part# Anchor Description Force Fiber Size (Strands) Implant Length SMT mm INSITE FT Ti Anchor w/needles Size 2- (Single strand) 8.5mm SMT mm INSITE FT Ti Anchor w/needles Size (Two strands) 1.mm SMT mm INSITE FT Ti Anchor w/needles Size #2 (Two strands) 18.mm SMT mm INSITE FT Ti Anchor w/needles Size #2 (Two strands) 18.mm SMP mm INSITE FT PEEK Anchor w/needles Size #2 (Two strands) 16.5mm SMP mm INSITE FT PEEK Anchor w/needles Size #2 (Two strands) 16.5mm SMB mm INSITE FT Biocomposite Anchor w/needles Size #2 (Two strands) 16.5mm SMB mm INSITE FT Biocomposite Anchor w/needles Size #2 (Two strands) 16.5mm SMK31 Tied 2.8mm PITON Anchor Size #2 (Two strands) 13.mm SMK11 Cinchable Knotless 3.5mm PITON Anchor Unloaded 13.6mm YKASMD INSITE FT Mini-Open Complete Instrument Set 123 Cherry Road Memphis, TN Nesbitt Avenue South Bloomington, MN Conexa is a trademark of LifeCell Corporation. Force Fiber is a trademark or registered trademark of Teleflex Incorporated. Ltd. FiberWire is a trademark or registered trademark of Arthrex, Inc. Ethibond is a trademark or registered trademark of Ethicon, a Johnson & Johnson Company. PEEK-OPTIMA is a trademark or registered trademarks of Invibio Ltd. Orthocord is a trademark or registered trademark of Depuy. and denote Trademarks and Registered Trademarks of Wright Medical Group N.V. or its affiliates. 216 Wright Medical Group N.V. or its affiliates. All Rights Reserved. CAW-6976 Rev B ECN Jun-216
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