# K092671: Variax Elbow System Line Extension

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 23, 2009 after 23 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.
No later device cites it as a predicate yet.
0 of 21 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.

## Indications for use
The VariAx Elbow System Line Extension is intended for fracture fixation of long bones. Indications include distal humerus and proximal ulna.

Source page: https://510kreport.com/device/K092671
Methodology: https://510kreport.com/methodology