# K211324: 2.4mm Distal Radius System

- Pathway: 510(k) (Traditional)
- Applicant: Auxein Medical Private Limited
- Decided: Mar 14, 2022 after 318 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: 1 generation back to K012114 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012114: Synthes Locking Distal Radius Plating System, Synthes (Usa) (2001) Summary page 5.

## Indications for use
2.4mm Wise-Lock Distal Radius System are used for displaced extra-articular and intra-articular distal radius fractures and corrective osteotomies of the distal radius. 2.4mm Wise-Lock Proximal Radius System are used for extra-articular and intra-articular fractures of Proximal radius and multifragmented radial neck fractures. 2.4mm Variable Angle Distal Radius System are used for displaced extra-articular and intra-articular distal radius fractures and corrective osteotomies of the distal radius.

Source page: https://510kreport.com/device/K211324
Methodology: https://510kreport.com/methodology