# K231684: Quick - Radius Disposable Set

- Pathway: 510(k) (Special)
- Applicant: GM Dos Reis Industria e Comercio Ltda.
- Decided: Jan 12, 2024 after 217 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: 11 generations back to K962616 (1996). 134 ancestors in all.
No later device cites it as a predicate yet.
0 of 135 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 3.

## Indications for use
Quick - Radius Disposable Set is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate and screw systems is suited for treatment of fractures in osteopenic bone.

Source page: https://510kreport.com/device/K231684
Methodology: https://510kreport.com/methodology