# K231188: ALIGN Radial Head System

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, Inc.
- Decided: Sep 28, 2023 after 155 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 K172688 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172688: Align Radial Head System, Skeletal Dynamics, LLC (2017) Summary page 4.

## Indications for use
The Align Radial Head System and accessories are designed specifically 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: o Joint destruction and/or subluxation, 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. The system is intended for press fit use.

Source page: https://510kreport.com/device/K231188
Methodology: https://510kreport.com/methodology