AlphaVent Biocomposite Suture Anchor - Fixation anchor, soft-tissue, biodegradable

Intended purpose

The AlphaVent Biocomposite Suture Anchor is intended to be used for fixation of suture (soft-tissue) to bone in the shoulder, foot and ankle, knee, hand and wrist, elbow and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures: - Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Capsular Shift or Capsulolabral Reconstruction - Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair - Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Quadriceps Tendon Repair, Secondary or adjunct fixation for ACL and PCL reconstruction or repair - Hand and Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction - Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair - Hip: Acetabular Labral Repair, Gluteal Tendon Repair

Functional description

The AlphaVent Biocomposite Suture Anchor is an absorbable soft-tissue fixation device with a screw-in design. The implant consists of a cannulated/vented anchor. The anchor is pre-assembled with various combinations of braided, non-absorbable surgical sutures that are provided both with and without needles. The implant assembly is provided on a disposable inserter. The anchor system is designed for insertion into bone by using instrumentation for creation of a pilot hole.