# K030384: Evolve Ceramic Radial Head Implant

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 12, 2003 after 188 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: 1 generation back to K960659 (1997). 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)
- K991915: Modular Radial Head, Wrightmedicaltechnologyinc (1999) Summary page 1.
- K960659: Ceramic Spherical CMC Implant (Subject to Marketing Approval), Wrightmedicaltechnologyinc (1997) Summary page 2.

## Indications for use
Use of the Modular Radial Head Implant may be considered for: Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: a. joint destruction and/or subluxation visible on x-ray; and/or b. resistance to conservative treatment. Primary replacement after fracture of the radial head. Symptomatic sequelae after radial head resection. Revision following failed radial head arthroplasty.

Source page: https://510kreport.com/device/K030384
Methodology: https://510kreport.com/methodology