# K213014: Varixis Elbow System

- Pathway: 510(k) (Traditional)
- Applicant: Auxein Medical Private Limited
- Decided: Oct 3, 2022 after 378 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 K962616 (1996). 80 ancestors in all.
No later device cites it as a predicate yet.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120070: Synthes Variable Angle LCP Elbow System, Synthes USA (2012) Summary page 6.

## Indications for use
The Auxein's Varixis Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.

Source page: https://510kreport.com/device/K213014
Methodology: https://510kreport.com/methodology