510(k) · Cleared
Recalled · Class II · 2026Osteonics Total Elbow System
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 May 5, 1998 after an 85-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled once.
- Decided
- May 5, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- JDC
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK980502 Osteonics Total Elbow SystemOsteonics Corp. · 1998
- Descendant · cites it directly · 1 of its ownK181362 TEMA Elbow SystemLima Corporate S.P.A. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK222807 TEMA Elbow system - Line extensionLima Corporate S.P.A. · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK983036 Single Axle Total ElbowBiomet, Inc. · 1999
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980502 | Osteonics Total Elbow System | Osteonics Corp. | 1998 | — |
| +1 | K181362 | TEMA Elbow System | Lima Corporate S.P.A. | 2019 | 1 |
| +2 | K222807 | TEMA Elbow system - Line extension | Lima Corporate S.P.A. | 2022 | 1 |
| +1 | K983036 | Single Axle Total Elbow | Biomet, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | — | Osteonics® Linked Semi-Constrained Total Elbow Prosthesis Named without a submission number |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2026 | Class II | Z-3195-2026 | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K181362 (Lima Corporate S.P.A., 2019) 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 | — |
What is it indicated for?
The indications for the Osteonics® Total Elbow System, in keeping with the legally marketed Osteonics® Linked Constrained Total Elbow Prosthesis, are as follows:
o Painful, disabling joint disease of the elbow resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
® Distal humeral fracture and/or dislocation.
° Revision of previous unsuccessful total elbow replacement, resurfacing, or other procedure.
° Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
o The Osteonics® Total Elbow System is indicated for cemented use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980502: Osteonics Total Elbow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980502
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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