# K112509: Trimed Clavicle Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Nov 4, 2011 after 66 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: 9 generations back to K962616 (1996). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100944: Clavicle Locking Plate System, Newclip Technics (2010) Summary page 1.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 1.

## Most influential descendants
- K230805: TriMed Clavicle Fixation System (2023), 0 descendants of its own

## Indications for use
The Clavicle Fixation System Plates and Screws are intended for use in fixation of fractures, mal-unions, non-unions, and osteotomies of the clavicle.

Source page: https://510kreport.com/device/K112509
Methodology: https://510kreport.com/methodology