# K033930: Kapp Custom Ulnar Head Wrist Implant

- Pathway: 510(k) (Traditional)
- Applicant: Kapp Surgical Instrument, Inc.
- Decided: Jul 28, 2004 after 223 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Avanta Ulnar Head Implant: named in the summary without a submission number

## Indications for use
The KAPP Patient Matched Ulnar Head Wrist Implant is intended to be used for: * Replacement of the distal radioulnar joint following ulnar head resection arthroplasty: * Replacement of the radial head for degenerative, rheumatoid, or post-traumatic disabilities presenting pain and weakness of the wrist joint and resistance to conservative treatment; * Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and * Failed ulnar head resection. * It is intended for patient matched use with bone cement and or press-fit fixation.

Source page: https://510kreport.com/device/K033930
Methodology: https://510kreport.com/methodology