# K001385: Howmedica Osteonics Radial Head Prothesis

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 27, 2000 after 86 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: 3 generations back to K944507 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944507: Metallic Radial Head Implants, Wrightmedicaltechnologyinc (1995) Summary page 1.
- K982288: Radial Head Implant, Avanta Orthopaedics, Inc. (1998) Summary page 1.
- K992220: Radial Head Prosthesis, Smith & Nephew, Inc. (2000) Summary page 1.

## Indications for use
The Howmedica Osteonics Radial Head Prosthesis is indicated for replacement of the proximal end of the radius in cases of rheumatoid arthritis; degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion of the radio-humeral and/or proximal radio-ulnar joint involving joint destruction and/or subluxation visible on x-ray; resistance to conservative treatment; fracture of the radial head; and symptomatic sequela after radial head resection. It is also indicated for use in revision procedures following failed radial head arthroplasty. This device is intended for cemented use only.

Source page: https://510kreport.com/device/K001385
Methodology: https://510kreport.com/methodology