# K221346: Stryker VariAx 2 MIS Calcaneus

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Jul 8, 2022 after 60 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: 5 generations back to K915818 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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.
- K132898: A.L.P.S. Calcaneal Plating System, Biomet Manufacturing Corp (2013) Summary page 4.

## Indications for use
Stryker VariAx 2 MIS Calcaneus is indicated for fractures of the calcaneus.

Source page: https://510kreport.com/device/K221346
Methodology: https://510kreport.com/methodology