# K102180: Rhead Radial Head Extended Stems

- Pathway: 510(k) (Traditional)
- Applicant: Small Bone Innovations, Inc.
- Decided: Dec 20, 2010 after 140 days
- Product code: JDB (Prosthesis, Elbow, Semi-Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3160
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K984290 (1999). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032686: Ascension Modular Radial Head, Ascension Orthopedics, Inc. (2003) Summary page 1.
- K060438: RHS, Tornier (2006) Summary page 1.

## Recalls of this device
- Oct 24, 2017 · Class II · Z-2704-2018: 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-2708-2018: 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-2703-2018: 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-2705-2018: 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-2709-2018: 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-2707-2018: 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-2706-2018: 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.
- Jun 24, 2015 · Class II · Z-2426-2015: 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-2429-2015: 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
Indications for use when used with a hemi-elbow implant: The SBi rHead Radial Head is indicated for use in 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: * Joint destruction or subluxation visible on x-ray * Resistance to conservative treatment Primary replacement after fracture of the radial head " Symptomatic sequelae after radial head resection * Revision following failed radial head arthroplasty Indications for use when used with a uni-elbow implant: The SBi Radial-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: * Non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis * Inflammatory degenerative joint disease including rheumatoid arthritis * Correction of functional deformity * Revision procedures where other treatments and devices have failed and * Treatment of fractures that are unmanageable using other technologies

Source page: https://510kreport.com/device/K102180
Methodology: https://510kreport.com/methodology