# K250935: TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: May 22, 2025 after 55 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: 12 generations back to K954385 (1996). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072740: Mondeal Extremity Bone Fixation System, Mondeal Medical Systems GmbH (2007) Summary page 5.
- K181820: Medline Unite Mini Plates and Screws, Medline Industries, Inc. (2018) Summary page 5.
- K133451: Fixos Screw System, Stryker Trauma AG (2014) Summary page 5.

## Indications for use
The TriMed Fifth Metatarsal System is indicated for use in stabilization of fractures, malunions and non-unions of the fifth metatarsal.

Source page: https://510kreport.com/device/K250935
Methodology: https://510kreport.com/methodology