# K251643: Synchfix EVT

- Pathway: 510(k) (Traditional)
- Applicant: Wright Medical Technology, Inc. (Stryker Corporation)
- Decided: Oct 29, 2025 after 153 days
- Product code: HTN (Washer, Bolt Nut)
- 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: 7 generations back to K792022 (1979). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170249: GRAVITY™ Syndesmosis LP, Wrightmedicaltechnologyinc (2017) Summary page 5.

## Indications for use
Synchfix EVT is intended for soft tissue and bone fixation for ankle syndesmosis disruptions with or without ankle fractures and as an adjunct in connection with hardware for ankle fractures such as Weber B, Weber C and Maisonneuve in adult and adolescent patient populations.

Source page: https://510kreport.com/device/K251643
Methodology: https://510kreport.com/methodology