# K052137: Ascension Muh

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Nov 3, 2005 after 90 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.
1 later device descends from it; 1 cites 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)
- K010786: Ulnar Head Implant, Avanta Orthopaedics, Inc. (2001) Summary page 1.

## Most influential descendants
- K112481: First Choice Druj System, Partial Head Implant (2012), 0 descendants of its own

## Indications for use
The Ascension® MUH is intended for replacement of the distal radioulnar joint: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis 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/K052137
Methodology: https://510kreport.com/methodology