# K133974: Variax Distal Radius Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH
- Decided: Mar 24, 2014 after 88 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: 4 generations back to K885250 (1989). 13 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040022: Stryker Leibinger Universal Distal Radius System, Stryker Leibinger (2004) Summary page 1.
- K100271: Vari AX Distal Radius Line Extensions of XXL Plates, Howmedica Osteonics Corp. (2010) Summary page 2.

## Most influential descendants
- K163361: ANTHEM™ Fracture System (2017), 14 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K202496: ANTHEM Fracture System (2020), 8 descendants of its own
- K212433: Anthem Fracture System (2021), 7 descendants of its own

## Indications for use
The VariAx Distal Radius Locking System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures. Indications for Use: Indications include: * compression fractures * intra-articular and extra-articular fractures * displaced fractures Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, non-unions, and malunions.

Source page: https://510kreport.com/device/K133974
Methodology: https://510kreport.com/methodology