# K140259: Variax Clavicle Hook Plate

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Apr 1, 2014 after 57 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: 11 generations back to K792022 (1979). 84 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 98 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)
- K130116: Superior Lateral Variax Clavicle Plate, Stryker Trauma AG (2013) Summary page 1.
- K030909: Aap Acroplate, Aap Implantate AG (2003) Summary page 2.
- K061753: Synthes (Usa) Clavicle Hook Plates, Synthes (Usa) (2006)

## Most influential descendants
- 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
- K213591: ANTHEM® Fracture System (2022), 5 descendants of its own

## Indications for use
Indicated for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions, and dislocations of the acromiaclavicular joint.

Source page: https://510kreport.com/device/K140259
Methodology: https://510kreport.com/methodology