# K212581: VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Jan 19, 2022 after 156 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: 15 generations back to K792022 (1979). 140 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133974: Variax Distal Radius Plating System, Stryker Leibinger GmbH (2014) Summary page 5.
- K191412: VariAx 2 System, VariAx 2 Mini Fragment System, Stryker GmbH (2019) Summary page 5.
- K060041: Trimed Bone Plates, TriMed, Inc. (2006) Summary page 5.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 5.

## Most influential descendants
- K233919: VariAx 2 Distal Radius System (2024), 2 descendants of its own
- K242343: BPS Wrist Fracture System (2024), 1 descendant of its own
- K250620: KLS Martin Ixos System (2025), 0 descendants 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. The VariAx 2 Distal Ulna System is indicated for the fixation of fractures, osteotomies, nonunions, and malunions of the wrist, including osteopenic bone.

Source page: https://510kreport.com/device/K212581
Methodology: https://510kreport.com/methodology