# K182718: Mini and Micro Fragments Reconstruction System – GMReis

- Pathway: 510(k) (Traditional)
- Applicant: Gm Dos Reis Industria E Comerico Ltda.
- Decided: Dec 23, 2019 after 451 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 K962616 (1996). 133 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 138 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142419: Mini and Micro Fragments Reconstruction System-NEOFIX, Neoortho Productos Orthopedicos S/A (2014) Summary page 4.
- K051567: Aptus Titanium Osteosynthesis System, Medartis, Inc. (2005) Summary page 4.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 4.
- K081546: Small Bone Locking Plating System, DePuy Orthopaedics, Inc. (2008) Summary page 4.
- K142906: APTUS Wrist 2.5 System, Medartis AG (2015) Summary page 4.

## Most influential descendants
- K242596: Versalock Mini and Micro Plating System (2024), 2 descendants of its own
- K260390: Super Upper Limbs Versalock Plating System (2026), 1 descendant of its own
- K262537: Versalock Sterile Plating System (2026), 0 descendants of its own
- K231684: Quick - Radius Disposable Set (2024), 0 descendants of its own

## Indications for use
Mini and Micro Fragments Reconstruction System - GMReis is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Source page: https://510kreport.com/device/K182718
Methodology: https://510kreport.com/methodology