# K191651: Arthrex Nano SwiveLock Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Nov 6, 2019 after 139 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 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 4.

## Indications for use
The Arthrex Nano SwiveLock Suture Anchor is intended to be used for suture or tissue fixation in the hand and wrist. Specific indications are listed below: Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers

Source page: https://510kreport.com/device/K191651
Methodology: https://510kreport.com/methodology