# K233971: Arthrex AlloSync PushLock Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jun 4, 2024 after 172 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: 2 generations back to K050749 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063479: Arthrex Pushlock, Arthrex, Inc. (2006) Summary page 5.

## Indications for use
The Arthrex AlloSync™ PushLock® suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, Superior Labrum from Anterior to Posterior (SLAP) Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Source page: https://510kreport.com/device/K233971
Methodology: https://510kreport.com/methodology
