# K010786: Ulnar Head Implant

- Pathway: 510(k) (Special)
- Applicant: Avanta Orthopaedics, Inc.
- Decided: Apr 11, 2001 after 27 days
- Product code: KXE (Prosthesis, Wrist, Hemi-, Ulnar)
- Device class: 2
- Regulation: 21 CFR 888.3810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K052137: Ascension Muh (2005), 1 descendant of its own
- K112481: First Choice Druj System, Partial Head Implant (2012), 0 descendants of its own
- K061146: Sbi Ulnar Head Implant (2006), 0 descendants of its own
- K042902: Herbert Ulnar Head Prosthesis System (2004), 0 descendants of its own
- K020274: WMT Modular Ulnar Head Implant (2002), 0 descendants of its own

## Recalls of this device
- Sep 6, 2013 · Class II · Z-0098-2014: The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box.

Source page: https://510kreport.com/device/K010786
Methodology: https://510kreport.com/methodology