510(k) · Cleared
Recalled · Class II · 2017Rhead Radial Head Extended Stems
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 Dec 20, 2010 as substantially equivalent to K032686 (Ascension Orthopedics, Inc., 2003) and 1 other predicate after a 140-day review. Its family tree reaches back 5 generations to 1999. It has been recalled 9 times.
- Decided
- Dec 20, 2010
- Review
- 140 days
- Class
- Class II
- Product code
- JDB
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 5 generations to K984290 (1999). 12 ancestors in all, the oldest K944507 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK984290 Implex Radial Head Replacement SystemImplex Corp. · 1999
- 4 generations backK012551 Liverpool Radial Head Replacement DeviceBiomet, Inc. · 2002
- 3 generations backK040611 Modular Radial Head Replacement DeviceBiomet, Inc. · 2004 · Recalled
- 2 generations backK051385 Explor Modular Radial Head Replacement DeviceBiomet, Inc. · 2005 · Recalled
- 1 generation backK060438 RHSTornier · 2006
- This deviceK102180 Rhead Radial Head Extended StemsSmall Bone Innovations, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K984290 | Implex Radial Head Replacement System | Implex Corp. | 1999 | — |
| −4 | K012551 | Liverpool Radial Head Replacement Device | Biomet, Inc. | 2002 | — |
| −3 | K040611 | Modular Radial Head Replacement Device | Biomet, Inc. | 2004 | 1 |
| −2 | K051385 | Explor Modular Radial Head Replacement Device | Biomet, Inc. | 2005 | 2 |
| −1 | K060438 | RHS | Tornier | 2006 | — |
| 0 (this device) | K102180 | Rhead Radial Head Extended Stems | Small Bone Innovations, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K032686 | Ascension Modular Radial HeadSummary page 1…ubstantially equivalent to other legally marketed SWi devices. The legally marketed predicate devices to which this device is substantially equivalent are the Ascension (K032686) and Tornier (K(060438) Radial Head Systems. Device Description: The SRi rI-ead, rHead Lateral, and rHead Recon prostheses are i… | 2003 |
| * | K060438 | RHSSummary page 1…to other legally marketed SWi devices. The legally marketed predicate devices to which this device is substantially equivalent are the Ascension (K032686) and Tornier (K(060438) Radial Head Systems. Device Description: The SRi rI-ead, rHead Lateral, and rHead Recon prostheses are implants that are intend… | 2006 |
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-2704-2018 | 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-2708-2018 | 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-2703-2018 | 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-2705-2018 | 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-2709-2018 | 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-2707-2018 | 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-2706-2018 | 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. |
| Jun 24, 2015 | Class II | Z-2426-2015 | Packaging change control | 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 | Packaging change control | 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. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 12 ancestors have a recall of any class.
- 2 other devices also cite its predicate K032686.
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. 2010, this device’s year, is highlighted.
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?
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…
Read the full statement (161 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102180: Rhead Radial Head Extended Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102180
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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