# K140376: Variax 2 System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Apr 3, 2014 after 48 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: 10 generations back to K962616 (1996). 84 ancestors in all.
23 later devices descend from it; 2 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)
- K063875: Stryker Foot Plating System, Howmedica Osteonics Corp. (2007) Summary page 2.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010)
- K101240: Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467, DePuy Orthopaedics, Inc. (2010) Summary page 2.

## Cited in the summary but kept off the family tree
- K091214: Footprint Medical Silicone Umbilical Catheter, Footprint Medical (2009). Our reading of the summary gave K091214, FDA’s number for Footprint Medical Silicone Umbilical Catheter (Footprint Medical). Its FDA name has none of the distinctive words the summary uses for the device it names, “Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K141992: Variax 2 System (2014), 22 descendants of its own
- 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

## 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/K140376
Methodology: https://510kreport.com/methodology