# K982268: Ulnar Head Implant

- Pathway: 510(k) (Traditional)
- Applicant: Avanta Orthopaedics, Inc.
- Decided: Dec 4, 1998 after 158 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) Silastic Swanson Ulnar Head Implant: named in the summary without a submission number

## Indications for use
Avanta Orthopaedics Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic disabilities presenting the following: Pain and weakness of the wrist joint not improved by conservative treatment Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes Failed ulnar head resection

Source page: https://510kreport.com/device/K982268
Methodology: https://510kreport.com/methodology