# K073527: Variax Elbow System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 14, 2008 after 59 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 6 generations back to K962616 (1996). 19 ancestors in all.
61 later devices descend from it; 6 cite it directly.
0 of 81 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.
- K062498: Profyle System, Howmedica Osteonics Corp. (2006) Summary page 2.
- K050512: Stryker Locked Plating System, Howmedica Osteonics Corp. (2005) Summary page 2.
- K040022: Stryker Leibinger Universal Distal Radius System, Stryker Leibinger (2004) Summary page 2.

## Most influential descendants
- K101056: Variax Elbow System (2010), 58 descendants of its own
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick (2012), 40 descendants of its own
- 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

## Indications for use
The VariAxTM Elbow System is intended for fracture fixation of long bones. Indications include: * Distal Humerus * Proximal Ulna

Source page: https://510kreport.com/device/K073527
Methodology: https://510kreport.com/methodology