# K250559: GMReis Fibula Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Gm Dos Reis Industria E Comercio
- Decided: Jun 12, 2025 after 107 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K960642 (1996). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143276: Acumed Small Bone IM Nail System, Acumed, LLC (2015) Summary page 5.

## Indications for use
The GMReis Fibula Nail System is intended for fixation of fractures and osteotomies of the fibula.

Source page: https://510kreport.com/device/K250559
Methodology: https://510kreport.com/methodology