# K132735: Axia Radial Head System

- Pathway: 510(k) (Traditional)
- Applicant: Imds (Innovative MEdical Device Systems) - Leis ME
- Decided: Jan 7, 2014 after 126 days
- Product code: KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991915 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060731: Evolve Modular Radial Head, Wrightmedicaltechnologyinc (2006) Summary page 1.

## Indications for use
Radial head replacement far degenerative or post-traumatic disabilities with pain; crepitatlon, and decreased motion at the radlo-humeral and or proximal radia-ulnar joint with: Joint destruction and/or subluxation Resistance to conservative treatment Primary radial head replacement after fracture Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty CAUTION: This device isintended for uncemented use only.

Source page: https://510kreport.com/device/K132735
Methodology: https://510kreport.com/methodology