510(k) · Cleared
ClearedTornier Total Elbow Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier · JDC Prosthesis, Elbow, Constrained, Cemented
Cleared on Oct 2, 2000 after a 273-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Oct 2, 2000
- Review
- 273 days
- Class
- Class II
- Product code
- JDC
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK000003 Tornier Total Elbow ProsthesisTornier · 2000
- Descendant · cites it directly · 7 of its ownK050848 Tornier Elbow ProsthesisTornier · 2005
- Descendant · cites it directly · 7 of its ownK031218 Modification to Tornier Total Elbow ProsthesisTornier · 2003
- Descendant · cites it directly · 6 of its ownK070787 Latitude Elbow ProthesisTornier · 2007
- Descendant · cites it directly · 5 of its ownK100562 Latitude Elbow ProsthesisTornier, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 4 of its ownK171010 Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K050848Tornier Elbow ProsthesisTornier · 2005 · cites it directly7descendants
- K031218Modification to Tornier Total Elbow ProsthesisTornier · 2003 · cites it directly7descendants
- K070787Latitude Elbow ProthesisTornier · 2007 · cites it directly6descendants
- K100562Latitude Elbow ProsthesisTornier, Inc. · 2010 · cites it directly5descendants
- K171010Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000003 | Tornier Total Elbow Prosthesis | Tornier | 2000 | — |
| +1 | K050848 | Tornier Elbow Prosthesis | Tornier | 2005 | — |
| +1 | K031218 | Modification to Tornier Total Elbow Prosthesis | Tornier | 2003 | — |
| +1 | K070787 | Latitude Elbow Prothesis | Tornier | 2007 | — |
| +1 | K100562 | Latitude Elbow Prosthesis | Tornier, Inc. | 2010 | 2 |
| +2 | K171010 | Latitude EV Total Elbow Arthroplasty | Tornier, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (9)
4 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, K050848 (Tornier, 2005) has gone furthest, with 7 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/K000003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000003: Tornier Total Elbow Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000003
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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