# K101056: Variax Elbow System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 13, 2010 after 28 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: 7 generations back to K962616 (1996). 20 ancestors in all.
58 later devices descend from it; 7 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073527: Variax Elbow System, Howmedica Osteonics Corp. (2008) Summary page 1.

## Most influential descendants
- 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
- K173135: VariAx 2 System (2017), 13 descendants of its own

## Indications for use
Distal Humerus Plates are indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension. Olecranon Plates are indicated for intra-articular or extra-articular fractures of the proximal ulna, osteotomies, and nonunions. Longer plates may be used for proximal ulna fractures with diaphyseal extension.

Source page: https://510kreport.com/device/K101056
Methodology: https://510kreport.com/methodology