# K140565: Variax 2 Compression Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: May 29, 2014 after 85 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 K981372 (1998). 13 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130009: Variax 2 Compression Plating System, Stryker Trauma AG (2013) Summary page 1.

## Most influential descendants
- K170727: VariAx 2 Compression Plating System (2017), 2 descendants of its own
- K211051: DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) (2021), 1 descendant of its own
- K254054: VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (2026), 0 descendants of its own

## Indications for use
The Stryker VariAx 2 Compression Plating System is indicated for internal fixation of fractures in the Radius, Ulna, Humerus, Clavicle, Distal tibia and Fibula for the following indications: osteotomies, mal-unions, and non-unions single, segmental, and comminuted fractures normal bone density and osteopenic bone

Source page: https://510kreport.com/device/K140565
Methodology: https://510kreport.com/methodology