# K042902: Herbert Ulnar Head Prosthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Stuckenbrock Medizintechnik GmbH
- Decided: Dec 27, 2004 after 68 days
- Product code: KXE (Prosthesis, Wrist, Hemi-, Ulnar)
- Device class: 2
- Regulation: 21 CFR 888.3810
- 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 K010786 (2001). 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)
- K010786: Ulnar Head Implant, Avanta Orthopaedics, Inc. (2001)

## Indications for use
The Herbert Ulnar Head Prosthesis System is indicated for ulnar head and stem replacement necessitated by: 1) Failed operative procedures such as Darrach, Bowers, or Sauve-Kapandji, 2) Primary osteoarthritis, 3) Post-traumatic osteoarthritis as a result of radial fractures, TFCC tears, ulnar impingement, 4) Rheumatoid arthritis, and 5) Tumors.

Source page: https://510kreport.com/device/K042902
Methodology: https://510kreport.com/methodology