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The Tornier CINCH™ Knotless Fixation Implant is intended for fixation of soft tissue to bone.

The CINCH™ Implant is intended for use in the following applications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

The CINCH™ Knotless Fixation Implant System includes a 3.5 mm diameter bone anchor and a disposable preloaded anchor Inserter. The CINCH™ Knotless Fixation Implant is designed to secure soft tissue to bone using USP #2 high strength non-absorbable UHMWPE braided suture. The CINCH™ system includes a Suture Loading Assembly that is attached to the distal end of the Inserter Handle. The CINCH™ Bone Anchor is a knotless fixation device eliminating the need for surgical knots. The device is designed for inserting the implant directly into bone without a pre-drilled, punched, or tapped pilot hole.

The CINCH™ Anchor configuration is comprised of a curved nitinol base, a flared nitinol clip, two titanium rings and a titanium cross pin. The CINCH™ Anchor is 12.9 mm long from rings to tip and 3.5 mm in diameter prior to wing deployment and 7.4 mm wide with wings expanded.

The provided text does not contain information about acceptance criteria or a study proving the device meets specific performance metrics. This submission, K080335, is a 510(k) summary, which focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving specific performance against acceptance criteria in a clinical study.

The document states: "This submission supports the position that the Tornier CINCH™ Knotless Fixation Implant System is substantially equivalent to a number of pre-enactment and previously cleared devices, including those listed above. A number of the referenced predicate devices list the same range of clinical uses."

And "Tornier, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Tornier CINCH™ Knotless Fixation Implant System. The materials from which the Tornier device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines."

This indicates that the device's acceptance is based on its similarity to existing, legally marketed devices and that it has been tested according to general FDA guidelines, not against specific performance acceptance criteria from a dedicated study detailed in this document.

Therefore, I cannot populate the requested table or answer the questions related to a specific study from this document.

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