# K030877: Trimed Radial Bullet

- Pathway: 510(k) (Traditional)
- Applicant: Tri-Med, Inc.
- Decided: Feb 5, 2004 after 322 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 K951303 (1995). 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)
- K951303: SFC, Medpac (1995) Summary page 1.
- (no number) Distal radius plate (Hand Innovations): named in the summary without a submission number
- (no number) Forte distal radius fixation plate (Zimmer): named in the summary without a submission number
- (no number) TriMed Radial Pin Plate (TriMed): named in the summary without a submission number
- (no number) Dorsal Nail Plate (Hand Innovations): named in the summary without a submission number
- (no number) Flexible Intramedullary Nail System for metacarpal fractures (Hand Innovations): named in the summary without a submission number

## Indications for use
The TriMed Radial Bullet is indicated for: 1. Fixation of fractures or non-unions of the distal radius 2. Osteotomies of the distal radius to correct malunion

Source page: https://510kreport.com/device/K030877
Methodology: https://510kreport.com/methodology