510(k) · Cleared
ClearedModified Single Axle Total Elbow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDC Prosthesis, Elbow, Constrained, Cemented
Cleared on Jun 27, 2000 after a 119-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Jun 27, 2000
- Review
- 119 days
- Class
- Class II
- Product code
- JDC
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK000683 Modified Single Axle Total ElbowBiomet, Inc. · 2000
- Descendant · cites it directly · 15 of its ownK033280 Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 9 of its ownK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
- Descendant · 2 generations on · 8 of its ownK043505 Discovery-Mosaic Total Humerus SystemBiomet, Inc. · 2005
- Descendant · 2 generations on · 7 of its ownK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 5 of its ownK143659 Equinoxe Mega ProsthesisExactech, Inc. · 2015
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K033280Discovery Elbow-Mosaic Distal Humeral Replacement SystemBiomet, Inc. · 2003 · cites it directly15descendants
- K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005 · 2 generations on9descendants
- K043505Discovery-Mosaic Total Humerus SystemBiomet, Inc. · 2005 · 2 generations on8descendants
- K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · 2 generations on7descendants
- K143659Equinoxe Mega ProsthesisExactech, Inc. · 2015 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000683 | Modified Single Axle Total Elbow | Biomet, Inc. | 2000 | — |
| +1 | K033280 | Discovery Elbow-Mosaic Distal Humeral Replacement System | Biomet, Inc. | 2003 | 1 |
| +2 | K042321 | Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head | Biomet Manufacturing Corp | 2005 | — |
| +2 | K043505 | Discovery-Mosaic Total Humerus System | Biomet, Inc. | 2005 | — |
| +2 | K111746 | Comprehensive Segmental Revision System (SRS) | Biomet, Inc. | 2011 | 1 |
| +3 | K143659 | Equinoxe Mega Prosthesis | Exactech, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033280 | Discovery Elbow-Mosaic Distal Humeral Replacement System | 2003 | 15 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033280 (Biomet, Inc., 2003) has gone furthest, with 15 descendants of its own.
How does its category compare?
All JDC devicesJDC Prosthesis, Elbow, Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDC
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JDC
Too few JDC 510(k)s in any year since 2007 to give a median.
Recalls per year · JDC
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDC
212in 2025
MAUDE reports naming product code JDC, 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 | 0 | — | 0 | 33 |
| 2008 | 0 | — | 2 | 47 |
| 2009 | 1 | — | 6 | 45 |
| 2010 | 0 | — | 0 | 86 |
| 2011 | 0 | — | 2 | 62 |
| 2012 | 0 | — | 2 | 79 |
| 2013 | 1 | — | 0 | 74 |
| 2014 | 0 | — | 0 | 79 |
| 2015 | 1 | — | 0 | 239 |
| 2016 | 1 | — | 0 | 176 |
| 2017 | 0 | — | 0 | 401 |
| 2018 | 0 | — | 0 | 248 |
| 2019 | 2 | — | 2 | 190 |
| 2020 | 0 | — | 0 | 179 |
| 2021 | 0 | — | 0 | 157 |
| 2022 | 0 | — | 0 | 129 |
| 2023 | 0 | — | 0 | 189 |
| 2024 | 0 | — | 0 | 175 |
| 2025 | 0 | — | 0 | 212 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K000683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000683: Modified Single Axle Total Elbow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000683
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026