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PONTiSTM Sutures with Optional Crimps are indicated to secure soft tissue to soft tissue reattachment in the hand: - Collateral Ligaments around the PIP, DIP and MCP Joints . - Flexor and Extensor Tendons . PONTiSTM Suture Anchors with Optional Crimps are indicated to secure soft tissue to bone reattachment in the hand: - Collateral Ligaments around the PIP, DIP and MCP Joints . - Flexor and Extensor Tendons .

This premarket notification covers line extensions for the PONTiS™ product line. The ferroFibre™ stainless steel (SS) sutures were cleared for marketing in 2008, and are marketed in the PONTiS ™ product group. The PONTiS™ product family has been expanded to include stainless steel suture anchors geometrically similar to the reNOVO™ titanium product family (cleared in 2007), in combination with ferroFibre™ SS Sutures and optional suture crimps. The PONTiS [1] implants incorporate non-absorbable ferroFibre [1] 316 L Stainless Steel Surgical sutures and are available in United States Pharmacopoeia (USP) sizes 4-0 and 3-0 in various lengths. 316L Stainless steel is used in a wide variety of medical devices including previously approved implants of this type. The ferroFibre™ Stainless Steel Sutures may be secured by either knot tying or crimping with a collar. The ferroFibre™ multifilament sutures are supplied sterile, armed with cutting needles. The implant components also include stainless steel collars specific to each suture size. The collars are used to secure multiple suture strands together simultaneously by crimping. For example, crimps are sized to accept between four (4) and eight (8) strands of each specific size of ferroFibre™ suture for crimping. A crimping instrument is supplied to crimp the collars to the suture strands. An adjustable tendon holder with suture tensioning slots is provided to facilitate suture cable tightening and tensioning. Excess suture is cut and removed. The stainless steel PONTiS™ Suture Anchors are 3.0mm in diameter, are selftapping, and fully threaded. The anchors are each available with 4-0 and 3-0 multistrand ferroFibre™ stainless steel sutures. A disposable anchor driver holds the excess suture and delivers the anchor directly into the bone. The strands are then used to secure the soft tissue to bone. Prior to installation, a hole is created in the bone using k-wire, drill or punch. The anchor is threaded into this hole. The anchor has self-tapping flutes. Unlike the previously cleared titanium reNOVO™ Suture Anchor, PONTiS™ Suture Anchors are fully threaded allowing thread fixation in both cancellous and cortical bone. The shorter overall length of the 3.0mm anchors, when compared to the self-drilling titanium reNOVO™ anchors, allows use in smaller/thinner bones where a lower profile is needed to achieve results without subsequent tissue injury. The PONTiS™ threaded suture anchors are stainless steel to assure compatibility with the stainless steel in the ferroFibre™ stainless steel multi-strand sutures and the stainless steel crimp collars. The size of the nonabsorbable stainless steel ferroFibre™ sutures used in the PONTiS™ Anchors is USP 4-0 and 3-0. A single use driver and hand piece holds the excess suture and delivers the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to bone. The PONTiS™ Suture Anchors are provided sterile for single use applications. The sizes and materials are designed to address the indications cited.

TAC-tite™ Suture Anchors are intended to secure soft tissue to bone of: The Shoulder: Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair The Elbow: Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair The Hand and Wrist: Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons The Ankle and Foot: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction

The TAC-tite™ Suture Anchors are available in 5.5mm and 7.0mm diameters. The TAC-tite™ Suture Anchors are available with a threaded titanium (ASTM F136/ ISO 5832-3) anchor body (that provides a self drilling and self tapping thread). The TAC-tite™ anchor eyelet is designed to accept size 2 (USP) nonabsorbable UHMW polyethylene UltraFibre™ sutures. A single use driver and handpiece delivers the preloaded anchor into the bone. The TAC-tite " Suture Anchor will be provided sterile for single use application.