Search Results

The Knotless Suture Fixation System is intended to secure soft tissue to bone of: The Shoulder, Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Rotator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair The Elbow: Ulnar or Radia! Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair The Hand and Wrist: Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Ankle/Foot Indications: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction

Knotless Suture Fixation System includes threaded anchors used to facilitate fixation of soft tissue to bone. This is a knotless suture anchor for surgical treatment of ligament, tendon and soft tissue pathologies of the shoulder and other joints. The implant is constructed of Polyetheretherketone (PEEK) which is widely used for products in the product code.

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.

ferroFibre 14 Stainless Steel Sutures are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.

The ferroFibre™ Stainless Steel Suture is available in United States Pharmacopocia (USP) sizes 5-0 to #5 in various lengths. The ferroFibre multifilament stainless stecl sutures are supplied storile, armed with cutting needles. The sutures are fabricated from 316 stainless steel that meets ASTM F138-03.

reVERTO™ Shape Memory Staples are intended for use in: Fixation of Osteotomies of the Hand, Foot and Tibia Arthrodesis of the Joints of the Hand and Foot Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament reVERTO™ Shape Memory Staples are also indicated for adjunctive fixation of Small Bone Fragments of: The Upper Extremity, such as the Radius, Ulna, Humerus, Clavicle and Scapula The Lower Extremity, such as the Tibia, Fibula and the Femur The Upper Torso, such as the Sternum and the Ribs

reVERTO™ Shape Memory Staples are dynamic compression implants that use shape memory metal nickel-titanium alloy called NiTinol (see below for more information on NiTinol). The NiTinol construction causes the legs of the implant to deflect, thereby creating a compressive force across the site of fixation. reVERTO Shape Memory Staples are advantageous to screws and plates in that they require less disruption of the surrounding bone for implantation and provide a 'low-profile' fixation. The most important factor related to the use of NiTinol is its ability to maintain a compressive force across the site of fixation during the healing process.

reNOVO 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 reNOVO™ Suture Anchors range in size from 2.0mm to 5.5mm in diameter. The anchor portion consists of a threaded titanium (ASTM F136/ ISO 5832-3) segment that provides a self drilling and self tapping thread. The anchor eyelet provides a means to attach the range of suture sizes utilized on the anchors. The size of sutures used in the reNOVO line range from size 3-0 thru size 2 (USP) nonabsorbable UHMW polyethylene UltraFibre™ sutures. A single use driver and handpiece hold the excess suture and deliver the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to the bone. The reNOVO™ Suture Anchor will be provided sterile for single use applications. The sizes and materials are designed to address the indications cited.