# K092721: Align Radial Head System

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, LLC
- Decided: Aug 3, 2010 after 333 days
- Product code: KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3170
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K984290 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041858: Acumed Anatomic Radial Head System, Acumed, LLC (2004) Summary page 1.
- K051385: Explor Modular Radial Head Replacement Device, Biomet, Inc. (2005) Summary page 1.

## Recalls of this device
- Oct 16, 2014 · Class II · Z-0582-2015: Report received where the Align Radial Stem fractured.

## 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/K092721
Methodology: https://510kreport.com/methodology