# K252061: Distal Xtremities System

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Aug 20, 2025 after 50 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 K915818 (1992). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050681: Omnitech System & Easy Lock Osteosystem with Xtremities Plates, TriMed, Inc. (2005) Summary page 5.

## Indications for use
The Tri Med Distal Xtremities System is indicated for use in stabilization of fractures, malunions and non-unions of the small bones of the foot.

Source page: https://510kreport.com/device/K252061
Methodology: https://510kreport.com/methodology