# K251945: TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)

- Pathway: 510(k) (Special)
- Applicant: TriMed, Inc.
- Decided: Jul 10, 2025 after 15 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: 15 generations back to K962616 (1996). 104 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102785: Trimed Radiocarpal Fusion System, TriMed, Inc. (2011) Summary page 5.
- K243999: TriMed Ankle Fixation System, TriMed, Inc. (2025) Summary page 5.

## Most influential descendants
- K262032: TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) (2026), 0 descendants of its own

## Indications for use
The TriMed Total Wrist fusion system is indicated for the following: 1. Wrist arthrodesis 2. Fractures of the wrist 3. Osteotomies of the wrist

Source page: https://510kreport.com/device/K251945
Methodology: https://510kreport.com/methodology