Device Dossier
AlphaVent Knotless SP Biocomposite Anchor - Fixation anchor, soft-tissue, biodegradable
Device Dossier for AlphaVent Knotless SP Biocomposite Anchor - Fixation anchor, soft-tissue, biodegradable (Fixation anchor, soft-tissue, biodegradable,…
- GMDN category: Fixation anchor, soft-tissue, biodegradable
- Sponsor: Stryker
Intended purpose
The AlphaVent Knotless SP Biocomposite Anchor is intended to be used for soft-tissue to bone fixation 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/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/PCL Reconstruction or Repair, Meniscal Root Repair - Hand/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 Knotless SP Biocomposite Anchor is a soft-tissue fixation device. The anchor consists of an eyelet and a screw. The anchor is provided preloaded on a disposable inserter. The anchor is provided in a sterile state and is intended for single use only. The anchor is designed for insertion into bone by either self-punching or by using instrumentation to create a pilot hole.