# K112481: First Choice Druj System, Partial Head Implant

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedic
- Decided: Apr 9, 2012 after 224 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: 2 generations back to K010786 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052137: Ascension Muh, Ascension Orthopedics, Inc. (2005) Summary page 1.

## Indications for use
The First Choice' Partial Ulnar Head implant is intended for partial replacement of the distal ulna for rheumatoid; degenerative, or post-traumatic arthritis presenting with pain and weakness localized to the distal radioulnar joint and not improved by conservative treatment. The First Choice Partial Ulnar Head implant is intended for press-fit use.

Source page: https://510kreport.com/device/K112481
Methodology: https://510kreport.com/methodology