# K243726: Osprey Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Responsive Arthroscopy, Inc.
- Decided: Jan 30, 2025 after 58 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K911837 (1991). 150 ancestors in all.
No later device cites it as a predicate yet.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173845: Arthrex SwiveLock, Arthrex, Inc. (2018) Summary page 5.
- K180951: Responsive Arthroscopy Suture Anchor System, Responsive Arthroscopy, LLC (2019) Summary page 5.

## Indications for use
The Osprey Suture Anchor is intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, and elbow in the following procedures: - Shoulder: Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. - Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy. - Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Meniscal Root Repair. Secondary fixation for ACL/PCL reconstruction. - Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

Source page: https://510kreport.com/device/K243726
Methodology: https://510kreport.com/methodology