# K141204: Variax 2 One Third Tubular Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Jun 20, 2014 after 42 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: 2 generations back to K000684 (2000). 3 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063875: Stryker Foot Plating System, Howmedica Osteonics Corp. (2007) Summary page 2.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001)

## Most influential descendants
- K151879: VariAx 2 One-Third Tubular Plating System (2015), 6 descendants of its own
- K231262: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System (2023), 4 descendants of its own
- K250163: T2 Alpha Femur Retrograde Nailing System (2025), 2 descendants of its own
- K253640: T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (2026), 1 descendant of its own
- K231257: Pangea Utility Plating System, Pangea Platform (2023), 1 descendant of its own

## Indications for use
The Stryker VariAx 2 One-Third Tubular Plating System is intended for internal fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, small bones in the ankle, fore, mid- and hind foot in adult patients. Indications include the following: *osteotomnies, and non-unions * fixation of fractures * normal bone density and osteopenic bone

Source page: https://510kreport.com/device/K141204
Methodology: https://510kreport.com/methodology