510(k) · Cleared
ClearedOsteonics Elbow Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteonics Corp. · JDC Prosthesis, Elbow, Constrained, Cemented
Cleared on Jun 27, 1986 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jun 27, 1986
- Review
- 57 days
- Class
- Class II
- Product code
- JDC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK861680 Osteonics Elbow ProsthesisOsteonics Corp. · 1986
- Descendant · cites it directly · 1 of its ownK980428 Biomet Biaxial Total ElbowBiomet, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK972691 Abc Total Elbow ProthesisBiomet, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK983036 Single Axle Total ElbowBiomet, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK982398 Biomet 100% Porous Coated Biaxial Total ElbowBiomet, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K980428Biomet Biaxial Total ElbowBiomet, Inc. · 1998 · cites it directly1descendant
- K972691Abc Total Elbow ProthesisBiomet, Inc. · 1997 · cites it directly1descendant
- K983036Single Axle Total ElbowBiomet, Inc. · 1999 · 2 generations on0descendants
- K982398Biomet 100% Porous Coated Biaxial Total ElbowBiomet, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861680 | Osteonics Elbow Prosthesis | Osteonics Corp. | 1986 | — |
| +1 | K980428 | Biomet Biaxial Total Elbow | Biomet, Inc. | 1998 | — |
| +1 | K972691 | Abc Total Elbow Prothesis | Biomet, Inc. | 1997 | — |
| +2 | K983036 | Single Axle Total Elbow | Biomet, Inc. | 1999 | — |
| +1 | K982398 | Biomet 100% Porous Coated Biaxial Total Elbow | Biomet, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 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? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K980428 (Biomet, Inc., 1998) has gone furthest, with 1 descendant 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/K861680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K861680: Osteonics Elbow Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K861680
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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