# K250528: Stryker AlphaVent™ Knotless SP Biocomposite Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: May 21, 2025 after 86 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K792022 (1979). 93 ancestors in all.
No later device cites it as a predicate yet.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233893: AlphaVent Knotless SP PEEK Anchor, Stryker Endoscopy (2024) Summary page 5.
- K203495: Arthrex SwiveLock Anchor, Arthrex, Inc. (2021) Summary page 5.

## Indications for use
The Stryker 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, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair • Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or Adjunct Fixation for ACL/PCL Reconstruction or Repair, Meniscal Root Repair, MPFL Repair/Reconstruction • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair • Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair, Proximal Hamstring Repair

Source page: https://510kreport.com/device/K250528
Methodology: https://510kreport.com/methodology