# K130116: Superior Lateral Variax Clavicle Plate

- Pathway: 510(k) (Special)
- Applicant: Stryker Trauma AG
- Decided: Mar 5, 2013 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 K792022 (1979). 80 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2012) Summary page 1.

## Most influential descendants
- K140259: Variax Clavicle Hook Plate (2014), 13 descendants of its own
- K173166: ANTHEM Fracture System (2017), 11 descendants of its own
- K180554: ANTHEM Fracture System (2018), 10 descendants of its own
- K202496: ANTHEM Fracture System (2020), 8 descendants of its own
- K212433: Anthem Fracture System (2021), 7 descendants of its own

## Indications for use
The Variax Clavicle Anterior/Superior Lateral and Anterior/Superior Midshafi Plates are indicated for fixation of single, segmental and comnminuted fractures, osteotomies, mal-unions, and non-unions of the clavicle.

Source page: https://510kreport.com/device/K130116
Methodology: https://510kreport.com/methodology