# K173135: VariAx 2 System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Nov 27, 2017 after 59 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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). 102 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140769: Variax 2 System, Stryker Trauma AG (2014) Summary page 4.
- K101240: Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467, DePuy Orthopaedics, Inc. (2010) Summary page 4.

## Most influential descendants
- K180500: VariAx 2 System (2018), 12 descendants of its own
- K191412: VariAx 2 System, VariAx 2 Mini Fragment System (2019), 10 descendants of its own
- K212581: VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System (2022), 4 descendants of its own
- K233919: VariAx 2 Distal Radius System (2024), 2 descendants of its own
- K220937: Arthrex Mini Fragment System (2022), 2 descendants of its own

## Indications for use
The VariAx 2 System is indicated for adult and pediatric patients, where the implant would not cross open growth plates, for the treatment of normal or osteopenic bone for the following conditions or procedures: Fracture fixation, including single, segmental, and comminuted fractures Revision, including nonunion and malunion Intra- and extra-articular fractures Compression fracture Displaced fracture Reconstruction Replantation Arthrodesis Osteotomy

Source page: https://510kreport.com/device/K173135
Methodology: https://510kreport.com/methodology