# K243740: Versalock Upper Limb Plating System

- Pathway: 510(k) (Traditional)
- Applicant: GM Dos Reis Industria e Comercio Ltda.
- Decided: Jan 29, 2025 after 56 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: 10 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)
- K123241: Arthrex Fracture Plates, Arthrex, Inc. (2013) Summary page 5.
- K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long, Synthes (Usa) (2004) Summary page 5.

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

## Indications for use
Versalock Upper Limb Plating System are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, and ulna.

Source page: https://510kreport.com/device/K243740
Methodology: https://510kreport.com/methodology