# K111971: Synde-Lock Syndesmosis Repair Kit

- Pathway: 510(k) (Traditional)
- Applicant: Tarsus Medical, Inc.
- Decided: Jan 23, 2012 after 196 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: 6 generations back to K792022 (1979). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 1.

## Indications for use
The Tarsus Synde-Lock Syndesmosis Repair Kit is intended to provide fixation during the healing process following a syndesmotic trauma.

Source page: https://510kreport.com/device/K111971
Methodology: https://510kreport.com/methodology