# K243987: TriMed Elbow and Forearm System

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Mar 19, 2025 after 86 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: 8 generations back to K962616 (1996). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060041: Trimed Bone Plates, TriMed, Inc. (2006) Summary page 5.
- K010545: TBW, Tri-Med, Inc. (2001) Summary page 5.

## Most influential descendants
- K262649: Alians Forearm (2026), 0 descendants of its own

## Indications for use
The following fracture configurations may be applicable for treatment using TriMed Elbow and Forearm System: 1. Fractures, malunions and non-unions of the radius and ulna amenable to plate and/or screw fixation where the size, shape and location of the fractured bone are appropriate for the specific implant(s) used. 2. Fractures and osteotomies of the olecranon.

Source page: https://510kreport.com/device/K243987
Methodology: https://510kreport.com/methodology