# K252959: WRISTAR MultiAx Distal Radius Kit

- Pathway: 510(k) (Traditional)
- Applicant: Intrauma S.P.A
- Decided: Nov 12, 2025 after 57 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 K071184 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083694: Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius Plates, Synthes (Usa) (2009) Summary page 5.
- K071184: Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System, Synthes (Usa) (2007) Summary page 5.

## Indications for use
The Wristar MultiAx Distal Radius Kit is indicated for: - Fixation of complex intra- and extra-articular fractures of the distal radius - osteotomies of the distal radius

Source page: https://510kreport.com/device/K252959
Methodology: https://510kreport.com/methodology