# K213563: DePuy Synthes Radial Head Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Synthes
- Decided: Mar 18, 2022 after 129 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 K991915 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183618: Revolution Radial Head, Ignite Orthopedics, Inc. (2019) Summary page 4.

## Indications for use
*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: o joint destruction and/or subluxation visible on x-ray; and/or o 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/K213563
Methodology: https://510kreport.com/methodology