# K052901: Arthrex Tensionlok

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: Dec 12, 2005 after 59 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 5 generations back to K904436 (1990). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031666: Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS, Arthrex, Inc. (2003) Summary page 1.

## Indications for use
The Arthrex TensionLokTM for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering this for ACL repair.

Source page: https://510kreport.com/device/K052901
Methodology: https://510kreport.com/methodology