# K250929: TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Jun 26, 2025 after 90 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: 2 generations back to K952766 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043263: Trimed Osteotomy Plate, TriMed, Inc. (2005) Summary page 5.

## Indications for use
TriMed Ulnar Osteotomy Plates are indicated for use in osteotomy procedures of the Ulna.

Source page: https://510kreport.com/device/K250929
Methodology: https://510kreport.com/methodology