# K192675: VariAx Foot

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Nov 22, 2019 after 57 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: 1 generation back to K063875 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063875: Stryker Foot Plating System, Howmedica Osteonics Corp. (2007) Summary page 4.

## Indications for use
The VariAx Foot system is intended for use in internal fixation, reconstruction or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures include but are not limited to: • Replantation • Lag screw techniques • Joint fusions • Corrective osteotomies • Treatment of fractures

Source page: https://510kreport.com/device/K192675
Methodology: https://510kreport.com/methodology