# K070236: Sbi Lateral Radio  Capitellum

- Pathway: 510(k) (Special)
- Applicant: Small Bone Innovations, Inc.
- Decided: Feb 21, 2007 after 27 days
- Product code: JDB (Prosthesis, Elbow, Semi-Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3160
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Recalls of this device
- Jun 24, 2015 · Class II · Z-2428-2015: 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.
- 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.

## Indications for use
The Small Bone Innovations' (SBi) Lateral Assembly Radio-Capitellar implant is indicated for use in the elbow for reduction or relief of win and/or improved elbow function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The SBi Lateral Assembly Radio-Capitellar implant is intended for cemented use only.

Source page: https://510kreport.com/device/K070236
Methodology: https://510kreport.com/methodology