# K992220: Radial Head Prosthesis

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 25, 2000 after 239 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 K944507 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982288: Radial Head Implant, Avanta Orthopaedics, Inc. (1998) Summary page 1.
- K944507: Metallic Radial Head Implants, Wrightmedicaltechnologyinc (1995) Summary page 1.
- K984290: Implex Radial Head Replacement System, Implex Corp. (1999) Summary page 1.

## Most influential descendants
- K001385: Howmedica Osteonics Radial Head Prothesis (2000), 0 descendants of its own

## Indications for use
The Radial Head Prosthesis is intended for replacement of the proximal end of the radius due to degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and/or proximal radio-ulnar joint involving joint destruction or subluxation visible on x-ray, reststance to conservative treatment; primary replacement after fracture of the radial head; and symptomatic sequelae after radial head resection.

Source page: https://510kreport.com/device/K992220
Methodology: https://510kreport.com/methodology