# K233919: VariAx 2 Distal Radius System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Mar 25, 2024 after 103 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: 16 generations back to K792022 (1979). 141 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 144 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212581: VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System, Stryker GmbH (2022) Summary page 4.

## Most influential descendants
- K242343: BPS Wrist Fracture System (2024), 1 descendant of its own
- K250498: BPS Wrist Fracture System (2025), 0 descendants of its own

## Indications for use
The VariAx 2 Distal Radius System is indicated for the fixation of fractures, osteotomies, nonunions and malunions of the bones of the hand and wrist, including osteopenic bone.

Source page: https://510kreport.com/device/K233919
Methodology: https://510kreport.com/methodology