# K262537: Versalock Sterile Plating System

- Pathway: 510(k) (Special)
- Applicant: GM Dos Reis Industria e Comercio Ltda.
- Decided: Aug 19, 2026 after 27 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: 13 generations back to K962616 (1996). 207 ancestors in all.
No later device cites it as a predicate yet.
0 of 208 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K260390: Super Upper Limbs Versalock Plating System, GM Dos Reis Industria e Comercio Ltda. (2026) Summary page 5.
- K242596: Versalock Mini and Micro Plating System, GM Dos Reis Industria e Comercio Ltda. (2024) Summary page 5.
- K242998: GMReis Ankle Plating System, GM Dos Reis Industria e Comercio Ltda. (2024) Summary page 5.
- K243740: Versalock Upper Limb Plating System, GM Dos Reis Industria e Comercio Ltda. (2025) Summary page 5.
- K182718: Mini and Micro Fragments Reconstruction System – GMReis, Gm Dos Reis Industria E Comerico Ltda. (2019) Summary page 5.
- K261406: Versalock Proximal Tibial Plating System, GM Dos Reis Industria e Comercio Ltda. (2026) Summary page 5.

## Indications for use
The Versalock Sterile Plating System is intended for fracture fixation, arthrodesis, reconstruction, osteotomy, fixation and non-unions of the hand, wrist, forearm, clavicle, scapula, olecranon, humerus, proximal tibia, foot and ankle. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Source page: https://510kreport.com/device/K262537
Methodology: https://510kreport.com/methodology