510(k) · Cleared
Recalled · Class II · 2017Sbi Radio-Capitellar Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Small Bone Innovations, Inc. · JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Cleared on Mar 30, 2006 as substantially equivalent to K011819 (Avanta Orthopaedics, Inc., 2001) after an 83-day review. Its family tree reaches back 1 generation to 2001. It has been recalled 11 times.
- Decided
- Mar 30, 2006
- Review
- 83 days
- Class
- Class II
- Product code
- JDB
- Recalls
- 11
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011819 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK011819 Radial Head ImplantAvanta Orthopaedics, Inc. · 2001 · Recalled
- This deviceK060038 Sbi Radio-Capitellar ImplantSmall Bone Innovations, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011819 | Radial Head Implant | Avanta Orthopaedics, Inc. | 2001 | 1 |
| 0 (this device) | K060038 | Sbi Radio-Capitellar Implant | Small Bone Innovations, Inc. | 2006 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDB device
- #1 K222807 TEMA Elbow system - Line extensionscore 4.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011819 | Radial Head Implant 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…be used with the radial stem components of the rHead and rHead Recon stem implants cleared for market under 510(k) K011819 and K023604 respectively. Intended Use: The SBI Radio-Capitellar implant is indicated for use in the… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 24, 2017 | Class II | Z-2694-2018 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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 | Under Investigation by firm | 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. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All JDB devicesJDB Prosthesis, Elbow, Semi-Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDB
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JDB
Too few JDB 510(k)s in any year since 2007 to give a median.
Recalls per year · JDB
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDB
38in 2025
MAUDE reports naming product code JDB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 6 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 44 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 1 | — | 0 | 26 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 0 | — | 0 | 31 |
| 2020 | 1 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 1 | — | 0 | 58 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 1 | 163 |
| 2025 | 0 | — | 0 | 38 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060038: Sbi Radio-Capitellar Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060038
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026