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 · JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Cleared on Jun 19, 2001 after a 29-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Jun 19, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- JDB
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK011567 Tornier Total Elbow ProsthesisTornier · 2001
- 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) | K011567 | Tornier Total Elbow Prosthesis | Tornier | 2001 | — |
| +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), 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?
The FDA summary names no predicate by number.
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 JDB devicesJDB Prosthesis, Elbow, Semi-Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Torier Total Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated in the following cases : to relieve severe pain or significant disability in degenerative, rheumatoid or traumatic disease of the elbow joint; correction of functional deformitics; revision procedures where other treatments or device have failed; treatment of fractures that are unmanageable using other techniqucs.
This device is intended 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/K011567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011567: 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/K011567
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026