# K254229: Arthrex Nano FiberTak Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Mar 2, 2026 after 63 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 K961555 (1996). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110879: Biomet Sports Medicine Juggerknot (TM) Mini Soft Anchor, Biomet Sports Medicine (2011) Summary page 5.
- K203268: Arthrex FiberTak Suture Anchor, Arthrex, Inc. (2020) Summary page 5.
- K181513: Arthrex PushLock Tenodesis Anchor, Arthrex, Inc. (2018) Summary page 5.

## Indications for use
The Nano FiberTak Suture Anchor is intended to be used for soft tissue to bone fixation with indications for use in: Hand and Wrist Ulnar or lateral collateral ligament reconstruction, Repair/reconstruction of collateral ligaments, flexor, and extensor tendon at the PIP (proximal interphalangeal, DIP (distal interphalangeal), and MCP (metacarpal interphalangeal) joints for all digits, Scapholunate ligament reconstruction.

Source page: https://510kreport.com/device/K254229
Methodology: https://510kreport.com/methodology