# K040497: Distal Radio-Ulnar Joint Implant

- Pathway: 510(k) (Traditional)
- Applicant: Aptis Medical, LLC
- Decided: Jan 26, 2005 after 335 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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 its predicate without a number.
- (no number) WMT Modular Ulnar Head Implant: named in the summary without a submission number

## Most influential descendants
- K142569: Aptis Medical Distal Radio Ulnar Joint Implant (2015), 1 descendant of its own
- K190599: Aptis Medical Distal Radio Ulnar Joint Implant (2019), 0 descendants of its own

## Indications for use
Aptis Medical Distal Radio 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 arthritis presenting with the following findings: * Pain and weakness of the wrist joint not improved by non-operative treatment * Instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint * Failed ulnar head resection; eg. Darrach resection * Primary replacement after fracture of the ulnar head or neck. * Revision following failed ulnar head arthroplasty.

Source page: https://510kreport.com/device/K040497
Methodology: https://510kreport.com/methodology