# K250948: TriMed Fusion Cup System

- Pathway: 510(k) (Special)
- Applicant: TriMed, Inc.
- Decided: Apr 8, 2025 after 18 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 following are osteosynthesis configurations that may be applicable to the TriMed Fusion Cups and Screws: 1. Arthrodesis of joints in the midfoot 2. Arthrodesis of the wrist and hand

Source page: https://510kreport.com/device/K250948
Methodology: https://510kreport.com/methodology