# K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Apr 25, 2012 after 126 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: 9 generations back to K792022 (1979). 79 ancestors in all.
40 later devices descend from it; 4 cite it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112111: Acu-Sinch Repair System and Acumed Suture Anchor, Acumed, LLC (2011) Summary page 1.
- K101536: 2.7/3.5MM VA-LCP Anteriro Clavicle Plate System, Synthes (Usa), LLC (2010) Summary page 1.
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K101056: Variax Elbow System, Howmedica Osteonics Corp. (2010) Summary page 1.
- K073527: Variax Elbow System, Howmedica Osteonics Corp. (2008) Summary page 1.
- K112455: Aiming Blocks for Variax Distal Radius Plates, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2011) Summary page 1.

## Most influential descendants
- K132502: Variax 2 System (2013), 21 descendants of its own
- K140769: Variax 2 System (2014), 19 descendants of its own
- K130116: Superior Lateral Variax Clavicle Plate (2013), 16 descendants of its own
- K173135: VariAx 2 System (2017), 13 descendants of its own
- K140259: Variax Clavicle Hook Plate (2014), 13 descendants of its own

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

Source page: https://510kreport.com/device/K113760
Methodology: https://510kreport.com/methodology