# K260624: Arthrex Radial Head Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jul 30, 2026 after 154 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 5.

## Indications for use
The Arthrex Radial Head Replacement System is indicated 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. The Cobalt Chrome stems are intended to be free floating and the Titanium Alloy stems are intended to be press-fit.

Source page: https://510kreport.com/device/K260624
Methodology: https://510kreport.com/methodology