# K151735: TriMed Humeral Supracondylar Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Jan 29, 2016 after 217 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). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 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 4.

## Indications for use
The following fracture configurations may be applicable for treatment using the TriMed Humeral Supracondylar Plates and TriMed Humeral Supracondylar Nail Plates: 1. Fractures of the humerus amenable to nail plate, plate and/or screw fixation where the size, shape, and location of the fractured bone are appropriate for the specific implant(s) being used. 2. The TriMed Humeral Supracondylar Fixation System intramedullary nail plate, plates and associated screws are intended for use in fixation of fractures of the distal humerus.

Source page: https://510kreport.com/device/K151735
Methodology: https://510kreport.com/methodology