# K222263: Arthrex Self Punching SwiveLock Suture Anchors

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Aug 26, 2022 after 29 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: 11 generations back to K792022 (1979). 89 ancestors in all.
No later device cites it as a predicate yet.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191226: Arthrex SwiveLock Suture Anchor, Arthrex, Inc. (2019) Summary page 4.

## Indications for use
The Arthrex Self Punching SwiveLock® Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in skeletally mature pediatric and adult patients. Specifically, rotator cuff repair.

Source page: https://510kreport.com/device/K222263
Methodology: https://510kreport.com/methodology