# K062898: Sbi Lateral Rhead Implant

- Pathway: 510(k) (Traditional)
- Applicant: Small Bone Innovations, Inc.
- Decided: Nov 13, 2006 after 47 days
- Product code: KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3170
- Recalls of this device: 14 (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
- Oct 24, 2017 · Class II · Z-2665-2018: 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-2673-2018: 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-2675-2018: 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-2672-2018: 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-2674-2018: 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-2666-2018: 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-2671-2018: 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-2669-2018: 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-2668-2018: 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-2663-2018: 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-2670-2018: 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-2664-2018: 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-2667-2018: 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.
- 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 SBi Lateral Assembly rHead is intended for replacement of the proximal end of the radius: 1. Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with: a. Joint destruction or subluxation visible on x-ray b. Resistance to conservative treatment 2. Primary replacement after fracture of the radial head 3. Symptomatic sequelae after radial head resection

Source page: https://510kreport.com/device/K062898
Methodology: https://510kreport.com/methodology