# K183628: Arthrex TensionLoc System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Mar 26, 2019 after 90 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: 3 generations back to K871037 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994202: Acufex Spiked Washer System, Acufex Suture Washer System, Acufex Cancellous Screw and Spiked Washer System, Smith & Nephew, Inc. (2000) Summary page 4.

## Indications for use
The Arthrex TensionLoc™ System is indicated for fixation of soft tissue, such as tendons and ligaments to bone in orthopedic procedures.

Source page: https://510kreport.com/device/K183628
Methodology: https://510kreport.com/methodology