# K261406: Versalock Proximal Tibial Plating System

- Pathway: 510(k) (Traditional)
- Applicant: GM Dos Reis Industria e Comercio Ltda.
- Decided: Jul 21, 2026 after 83 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: 9 generations back to K000684 (2000). 76 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112437: Arthrex Fracture System, Arthrex, Inc. (2011) Summary page 5.
- K202489: AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System, Advanced Orthopaedic Solutions, Inc. (2020) Summary page 5.

## Most influential descendants
- K262537: Versalock Sterile Plating System (2026), 0 descendants of its own

## Indications for use
The Versalock Proximal Tibial Plating System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and nonunions in the proximal tibia.

Source page: https://510kreport.com/device/K261406
Methodology: https://510kreport.com/methodology