# K043263: Trimed Osteotomy Plate

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Jan 14, 2005 after 51 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952766 (1995). 2 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952766: Rayhack Osteotomy System (Modification), Creative Medical Designs, Inc. (1995) Summary page 1.
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K141232: Aptus Ulna Shortening 2.5 (2014), 5 descendants of its own
- K260390: Super Upper Limbs Versalock Plating System (2026), 1 descendant of its own
- K211592: Avanti Orthopaedics Ulnar Shortening System (2021), 1 descendant of its own
- K130008: Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous Locking Screw, 3.0 Cortical Locking (2013), 1 descendant of its own
- K262649: Alians Forearm (2026), 0 descendants of its own

## Recalls of this device
- Apr 16, 2018 · Class II · Z-2877-2018: Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate

## Indications for use
The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.

Source page: https://510kreport.com/device/K043263
Methodology: https://510kreport.com/methodology