# K141677: Variax Elbow Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Trauma AG
- Decided: Jul 22, 2014 after 29 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: 8 generations back to K962616 (1996). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101056: Variax Elbow System, Howmedica Osteonics Corp. (2010) Summary page 1.
- K033995: 3.5 MM LCP Distal Humerus System, Synthes (Usa) (2004) Summary page 2.

## Indications for use
The VariAx Elbow Plating System is intended for fracture fixation of long bones. The distal humerus plates are indicated for: * intra-articular or extraarticular fractures of the distal humerus * osteotomies * nonunions The olecranon plates are indicated for: * intra-articular or extraarticular fractures of the proximal ulna * osteotomies * nonunions

Source page: https://510kreport.com/device/K141677
Methodology: https://510kreport.com/methodology