# K151178: VariAx 2 Wrist Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Jun 24, 2015 after 51 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 K000558 (2000). 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)
- K000558: Synthes (Usa) Wrist Fusion Plates (WFP), Synthes (Usa) (2000) Summary page 5.

## Indications for use
The Stryker VariAx 2 Wrist Fusion System is indicated for wrist arthrodesis and fixation of fractures in patients with wrist arthritis or fractures of other small bones of the carpus. Specific indications include: • Post-traumatic arthritis of the joints of the wrist • Rheumatoid wrist deformities requiring restoration • Complex carpal instability • Post-septic arthritis of the wrist • Severe unremitting wrist pain related to motion • Brachial plexus nerve palsies • Tumor resection • Spastic deformities

Source page: https://510kreport.com/device/K151178
Methodology: https://510kreport.com/methodology