# K141430: Variax Distal Radius Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Leibinger GmbH & Co KG
- Decided: Jul 18, 2014 after 49 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: 8 generations back to K962616 (1996). 29 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060041: Trimed Bone Plates, TriMed, Inc. (2006) Summary page 2.

## Most influential descendants
- K162841: VariAx Distal Radius Plating System, VariAx 2 System (2017), 4 descendants of its own
- K161292: Distal Radius Plating System (2016), 4 descendants of its own
- K191641: AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws (2019), 3 descendants of its own
- K162635: Distal Radius Plating System (2016), 2 descendants of its own
- K242343: BPS Wrist Fracture System (2024), 1 descendant 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 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/K141430
Methodology: https://510kreport.com/methodology