# K142569: Aptis Medical Distal Radio Ulnar Joint Implant

- Pathway: 510(k) (Traditional)
- Applicant: Aptis Medical, LLC
- Decided: Apr 3, 2015 after 203 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 K040497 (2005). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040497: Distal Radio-Ulnar Joint Implant, Aptis Medical, LLC (2005) Summary page 4.
- K053119: Distal Radio-Ulnar Joint Implant, Aptis Medical, LLC (2005) Summary page 4.
- K082839: Distal Radio-Ulnar Joint Implant, Aptis Medical, LLC (2008) Summary page 4.

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

## Indications for use
The Aptis Medical Distal Radio Ulnar Joint 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; e.g. Darrach resection • Primary replacement after fracture of the ulnar head or neck. • Revision following failed ulnar head arthroplasty. This prosthesis is intended for single use only.

Source page: https://510kreport.com/device/K142569
Methodology: https://510kreport.com/methodology