# K130009: Variax 2 Compression Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Mar 22, 2013 after 79 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K981372 (1998). 12 ancestors in all.
27 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 2.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 2.

## Most influential descendants
- K132502: Variax 2 System (2013), 21 descendants of its own
- K140769: Variax 2 System (2014), 19 descendants of its own
- K173135: VariAx 2 System (2017), 13 descendants of its own
- K180500: VariAx 2 System (2018), 12 descendants of its own
- K191412: VariAx 2 System, VariAx 2 Mini Fragment System (2019), 10 descendants of its own

## Recalls of this device
- Oct 10, 2013 · Class II · Z-1507-2016: Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.

## 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, mat-unions, and non-unions * single, segmental, and comminuted fractures normal bone density and osteopenic bone

Source page: https://510kreport.com/device/K130009
Methodology: https://510kreport.com/methodology