# K230805: TriMed Clavicle Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Sep 1, 2023 after 162 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: 10 generations back to K962616 (1996). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112509: Trimed Clavicle Fixation System, TriMed, Inc. (2011) Summary page 4.
- K201321: DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes (2020) Summary page 4.

## Indications for use
The TriMed Clavicle Fixation Plates and Screws are indicated for use in fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.

Source page: https://510kreport.com/device/K230805
Methodology: https://510kreport.com/methodology