# K172688: Align Radial Head System

- Pathway: 510(k) (Special)
- Applicant: Skeletal Dynamics, LLC
- Decided: Dec 22, 2017 after 107 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K231188: ALIGN Radial Head System (2023), 0 descendants of its own

## 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 sequeclae after radial head resection. * Revision following failed radial head arthroplasty. The system is intended for press fit use.

Source page: https://510kreport.com/device/K172688
Methodology: https://510kreport.com/methodology