# K132502: Variax 2 System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Oct 23, 2013 after 75 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 K792022 (1979). 97 ancestors in all.
21 later devices descend from it; 4 cite it directly.
0 of 119 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080667: Variax Distal Radius Torx Screws, Howmedica Osteonics Corp. (2008) Summary page 3.
- K100271: Vari AX Distal Radius Line Extensions of XXL Plates, Howmedica Osteonics Corp. (2010) Summary page 3.
- K063875: Stryker Foot Plating System, Howmedica Osteonics Corp. (2007) Summary page 3.
- K081284: Variax Distal Fibula Plate, Howmedica Osteonics Corp. (2008) Summary page 3.
- K102282: The Varia Fibula Locked Plating System Line Extension Addition of Straight Plates, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2010) Summary page 3.
- K073527: Variax Elbow System, Howmedica Osteonics Corp. (2008) Summary page 3.
- K101056: Variax Elbow System, Howmedica Osteonics Corp. (2010) Summary page 3.
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2012) Summary page 3.
- K130009: Variax 2 Compression Plating System, Stryker Trauma AG (2013) Summary page 3.
- K000636: Stryker Trauma Plating System, Howmedica Osteonics Corp. (2000) Summary page 3.

## Most influential descendants
- 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
- K212581: VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System (2022), 4 descendants of its own

## Indications for use
The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for: * Internal fracture fixation; * Osteotomies; * Revision procedures such as non-unions or mal-unions; In addition, the following indications are specific to the devices listed below: * T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of: o Compression fractures; o lntra-ai-ticular and extra-articular fractures; o Displaced fractures; o Reconstruction procedures; * T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, mid- and hind Foot and Ankle, in the treatment of: o lntra-articular and extra-articular fractures of the Distal Radius, o Displaced and compression fractures of the Distal Radius; o Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o Reconstruction procedures in the Foot & Ankle and Distal Radius; * TIO 3.5mm and TIO 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of:, o Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; o Single, segmental and comminuted fractures; o Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; o Normal bone density or osteopenic bone.

Source page: https://510kreport.com/device/K132502
Methodology: https://510kreport.com/methodology