# K253895: Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Dec 30, 2025 after 26 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: 8 generations back to K961555 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150648: Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm, Arthrex, Inc. (2015) Summary page 5.

## Indications for use
The Arthrex Swivelock Suture Anchor, 3.5 x 10 mm is intended to be used for suture or tissue fixation in the foot/ankle and hand/wrist. Specific indications for use are listed below: • Hand/Wrist: Repair of Collateral Ligaments, Repair of Flexor and Extensor Tendous at the PIP, DIP and MCP joints for all digits and Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty) • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus Reconstruction

Source page: https://510kreport.com/device/K253895
Methodology: https://510kreport.com/methodology