# K162841: VariAx Distal Radius Plating System, VariAx 2 System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Feb 21, 2017 after 133 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: 12 generations back to K792022 (1979). 107 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141430: Variax Distal Radius Plating System, Stryker Leibinger GmbH & Co KG (2014) Summary page 6.
- K140769: Variax 2 System, Stryker Trauma AG (2014) Summary page 6.

## Most influential descendants
- 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
- K242343: BPS Wrist Fracture System (2024), 1 descendant of its own
- K250498: BPS Wrist Fracture System (2025), 0 descendants of its own
- K220199: AFFINITY Proximal Tibia System (2022), 0 descendants of its own

## Indications for use
The VariAx Distal Radius Plating 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 mal-unions. The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for: « Internal fracture fixation; * Osteotomies; » Revision procedures such as non-unions or mal-unions; In addition, the following indications are specific to the devices listed below: * T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of: o Compression fractures; o Intra-articular and extra-articular fractures; o Displaced fractures; o Reconstruction procedures; » T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, mid- and hind Foot and Ankle, in the treatment of: o Intra-articular and extra-articular fractures of the Distal Radius, o Displaced and compression fractures of the Distal Radius; o Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o Reconstruction procedures in the Foot & Ankle and Distal Radius; * TI0 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of: o Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; o Single, segmental and comminuted fractures; o Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o Normal bone density or osteopenic bone.

Source page: https://510kreport.com/device/K162841
Methodology: https://510kreport.com/methodology