# K141992: Variax 2 System

- Pathway: 510(k) (Special)
- Applicant: Stryker Trauma AG
- Decided: Aug 7, 2014 after 16 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: 11 generations back to K962616 (1996). 85 ancestors in all.
22 later devices descend from it; 3 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140376: Variax 2 System, Stryker Trauma AG (2014) Summary page 4.

## Most influential descendants
- K162674: BioPro Foot Plating Systems (2017), 19 descendants of its own
- K193222: Tyber Medical Anatomical Plating System (2020), 11 descendants of its own
- K203817: Tyber Medical Anatomical Plating System (2021), 10 descendants of its own
- K222465: Tyber Medical Anatomical Plating System (2023), 9 descendants of its own
- K183011: Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (2019), 5 descendants of its own

## Indications for use
The Stryker VariAx 2 System is intended for use in internal fixation, reconstruction and treatment of fractures in the foot and ankle in adult and adolescent (12-21 years) patients. Including: * Replantation * Joint fusions * Corrective osteotomies * Osteopenic bone

Source page: https://510kreport.com/device/K141992
Methodology: https://510kreport.com/methodology