# K222637: TriMed Wrist Fixation System 3

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Dec 21, 2022 after 112 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951303 (1995). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040112: Trimed Bearing Plate; Trimed Volar Bearing Plate, Tri-Med, Inc. (2004) Summary page 4.
- K951302: Small Fragment Plates and Screws, Medpac (1995) Summary page 4.
- K951303: SFC, Medpac (1995) Summary page 4.
- K010545: TBW, Tri-Med, Inc. (2001) Summary page 4.

## Most influential descendants
- K251732: Wrist Fracture System (2026), 0 descendants of its own
- K254002: TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) (2026), 0 descendants of its own
- 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); (2025), 0 descendants of its own

## Recalls of this device
- Nov 28, 2023 · Class II · Z-0932-2024: Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.

## Indications for use
TriMed Volar Plates and Radial Peg Plates The following fracture configurations may be applicable for treatment using the TriMed Volar Plates and Radial Peg Plates: 1. 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 The following fracture configurations may be applicable for treatment using the 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 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.

Source page: https://510kreport.com/device/K222637
Methodology: https://510kreport.com/methodology