# K170771: VariAx 2 Foot System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: May 8, 2017 after 55 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 K962616 (1996). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141992: Variax 2 System, Stryker Trauma AG (2014) Summary page 4.
- K090692: Ortholoc 2.0/2.4 Plate System, Wrightmedicaltechnologyinc (2009) Summary page 4.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 4.

## Indications for use
VariAx 2 Foot System is indicated for internal fixation of bones in the foot, ankle, hand, and wrist in adult and adolescent (12 - 21 years) patients, which includes replantation, joint fusions, corrective osteotomies, and osteopenic bone.

Source page: https://510kreport.com/device/K170771
Methodology: https://510kreport.com/methodology