Class Class II
GMReis Fibula Nail System (K250559)
Description
GMReis Fibula Nail System by Gm Dos Reis Industria E Comercio, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250559
Clearance Date2025-06-12
Clearance TypeTraditional
Product CodeHSB
Regulation Number888.3020
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250559
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. GMReis Fibula Nail System (K250559) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232829 | Versalock Rib and Sternum Plates System | GM Dos Reis Industria e Comercio Ltda. | 2024 |
| K223114 | Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors | Gm Dos Reis Industria E Comerico Ltda. | 2023 |
| K201728 | Versalock Periprosthetic Femur Plates System-GMReis | GM Dos Reis Industria e Comercio Ltda. | 2021 |
| K143276 | Acumed Small Bone IM Nail System | Acumed, LLC | 2015 |
| K102998 | CONGRUENT BONE PLATE SYSTEM | Acumed, LLC | 2011 |
Trace the full predicate network for K250559
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.