# K243050: TriMed Posterior Malleolus Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Nov 26, 2024 after 60 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: 1 generation back to K080522 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080522: Synthes 3.5 MM LCP Distal Tibia T Plates, Synthes (Usa) (2008) Summary page 6.

## Indications for use
TriMed Posterior Malleolus Fixation System is indicated for fractures, osteotomies, and non-unions of the distal tibia.

Source page: https://510kreport.com/device/K243050
Methodology: https://510kreport.com/methodology