# K112030: Synthes Radial Head Prosthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA, LLC
- Decided: Jun 19, 2012 after 340 days
- Product code: KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3170
- Recalls of this device: 2 (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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051385: Explor Modular Radial Head Replacement Device, Biomet, Inc. (2005) Summary page 2.
- K032686: Ascension Modular Radial Head, Ascension Orthopedics, Inc. (2003) Summary page 1.

## Recalls of this device
- Dec 29, 2016 · Class II · Z-1124-2017: There is the possibility that the radial stem may loosen post-operatively at the stem bone interface.
- Feb 22, 2013 · Class II · Z-1238-2013: The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being init

## Indications for use
The Synthes Radial Head Prosthesis System is intended for: 1. The replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radlo-humeral and/or proximal radlo-ulnar joint with a. Joint destruction and/or subluxation visible on x-ray b. Resistance to conservative treatment 2. Primary replacement after fracture of the radial head. 3. Symptomatic sequelae after radial head resection 4. Revision following failed radial head arthroplasty.

Source page: https://510kreport.com/device/K112030
Methodology: https://510kreport.com/methodology