# K260390: Super Upper Limbs Versalock Plating System

- Pathway: 510(k) (Traditional)
- Applicant: GM Dos Reis Industria e Comercio Ltda.
- Decided: Mar 17, 2026 after 39 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: 12 generations back to K962616 (1996). 200 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 202 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182718: Mini and Micro Fragments Reconstruction System – GMReis, Gm Dos Reis Industria E Comerico Ltda. (2019) Summary page 5.
- K242596: Versalock Mini and Micro Plating System, GM Dos Reis Industria e Comercio Ltda. (2024) Summary page 5.
- K142906: APTUS Wrist 2.5 System, Medartis AG (2015) Summary page 5.
- K123241: Arthrex Fracture Plates, Arthrex, Inc. (2013) Summary page 5.
- K172170: APTUS (R) Wrist 2.5 System, Medartis AG (2017) Summary page 5.
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX, Neoortho Productos Orthopedicos S/A (2014) Summary page 5.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 5.
- K141232: Aptus Ulna Shortening 2.5, Medartis AG (2014) Summary page 6.
- K951302: Small Fragment Plates and Screws, Medpac (1995) Summary page 6.

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

## Indications for use
The Super Upper Limbs Versalock Plating System is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand, wrist and forearm. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Source page: https://510kreport.com/device/K260390
Methodology: https://510kreport.com/methodology