# K201728: Versalock Periprosthetic Femur Plates System-GMReis

- Pathway: 510(k) (Traditional)
- Applicant: GM Dos Reis Industria e Comercio Ltda.
- Decided: Mar 8, 2021 after 258 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: 6 generations back to K981372 (1998). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120772: NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial Locking Plate, Zimmer GmbH (2012) Summary page 5.

## Indications for use
The Versalock Periprosthetic Femur Plates System — GMReis is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the femur, including: * Periprosthetic fractures » Comminuted fractures * Supracondylar fractures * Trochanteric fractures * Fractures in normal and osteopenic bone * Non-unions and Malunions.

Source page: https://510kreport.com/device/K201728
Methodology: https://510kreport.com/methodology