# K243569: TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Jan 15, 2025 after 58 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: 3 generations back to K951303 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222637: TriMed Wrist Fixation System 3, TriMed, Inc. (2022) Summary page 7.

## Indications for use
Specific indications for use of the subject devices in Wrist Fixation System are as follows: TriMed Volar Plates and Radial Peg Plates: Fractures, non-unions or osteotomies of the distal radius. TriMed Ulnar Peg Plates: Fractures, non-unions and osteotomies of the distal end of the ulna. TriMed Pin Plates: 1. Fractures of the radial column of the wrist. 2. Fractures of the dorsal ulnar cortex of the distal radius. TriMed Wire Forms, Shear Plates and Hook Plates Fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone. TriMed Radial Osteotomy System is indicated for osteotomies of the distal radius. TriMed Welded Wire Forms in Wrist Fixation System 3 is indicated for Fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone.

Source page: https://510kreport.com/device/K243569
Methodology: https://510kreport.com/methodology