# K060038: Sbi Radio-Capitellar Implant

- Pathway: 510(k) (Traditional)
- Applicant: Small Bone Innovations, Inc.
- Decided: Mar 30, 2006 after 83 days
- Product code: JDB (Prosthesis, Elbow, Semi-Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3160
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011819 (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)
- K011819: Radial Head Implant, Avanta Orthopaedics, Inc. (2001). Our reading of the summary gave “K011819” beside “510(k)”; FDA’s K011819 is the only number that fits it and carries the summary’s name for the device. Summary page 1.

## Recalls of this device
- Oct 24, 2017 · Class II · Z-2694-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2710-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2698-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2699-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2696-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2702-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2701-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2695-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2693-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2697-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
- Oct 24, 2017 · Class II · Z-2700-2018: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

## Indications for use
The SBI Radio-Capitellar implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions: 1)non-inflanmatory 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 Avanta Radio-Capitellar implant is intended for cemented use only.

Source page: https://510kreport.com/device/K060038
Methodology: https://510kreport.com/methodology