# K061146: Sbi Ulnar Head Implant

- Pathway: 510(k) (Special)
- Applicant: Small Bone Innovations, Inc.
- Decided: Jul 19, 2006 after 85 days
- Product code: KXE (Prosthesis, Wrist, Hemi-, Ulnar)
- Device class: 2
- Regulation: 21 CFR 888.3810
- Recalls of this device: 2 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Recalls of this device
- Jun 24, 2015 · Class II · Z-2430-2015: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
- Jun 24, 2015 · Class II · Z-2427-2015: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.

## Indications for use
The SBI 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 disabilities 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, and failed ulnar head resection.

Source page: https://510kreport.com/device/K061146
Methodology: https://510kreport.com/methodology