510(k) · Cleared
ClearedLATITUDE EV Total Elbow Arthroplasty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Cleared on Dec 27, 2018 as substantially equivalent to K100562 (Tornier, Inc., 2010) and 1 other predicate after a 108-day review. Its family tree reaches back 6 generations to 1989. 1 later device descends from it.
- Decided
- Dec 27, 2018
- Review
- 108 days
- Class
- Class II
- Product code
- JDB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K883665 (1989). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK883665 Coonrad Iii Total ElbowZimmer, Inc. · 1989
- 5 generations backK973357 Coonrad/Morrey Total Elbow, New Hinge PinZimmer, Inc. · 1998 · Recalled
- 4 generations backK031218 Modification to Tornier Total Elbow ProsthesisTornier · 2003
- 3 generations backK070787 Latitude Elbow ProthesisTornier · 2007
- 2 generations backK100562 Latitude Elbow ProsthesisTornier, Inc. · 2010 · Recalled
- 1 generation backK171010 Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017
- This deviceK182461 LATITUDE EV Total Elbow ArthroplastyTornier, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK193247 LATITUDE EV™ Total Elbow ArthroplastyTornier, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K193247LATITUDE EV™ Total Elbow ArthroplastyTornier, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K883665 | Coonrad Iii Total Elbow | Zimmer, Inc. | 1989 | — |
| −5 | K973357 | Coonrad/Morrey Total Elbow, New Hinge Pin | Zimmer, Inc. | 1998 | 1 |
| −4 | K031218 | Modification to Tornier Total Elbow Prosthesis | Tornier | 2003 | — |
| −3 | K070787 | Latitude Elbow Prothesis | Tornier | 2007 | — |
| −2 | K100562 | Latitude Elbow Prosthesis | Tornier, Inc. | 2010 | 2 |
| −1 | K171010 | Latitude EV Total Elbow Arthroplasty | Tornier, Inc. | 2017 | — |
| 0 (this device) | K182461 | LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. | 2018 | — |
| +1 | K193247 | LATITUDE EV™ Total Elbow Arthroplasty | Tornier, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K100562 | Latitude Elbow ProsthesisSummary page 4…JDC Predicate Device Information Predicate: LATITUDE EV™ Total Elbow Arthroplasty (LATITUDE™ Elbow Prosthesis) 510(k) Number: K100562, K171010 Reference Device: RHS 510(k) Number: K060438 Device Description The Latitude EV™ Total Elbow Arthroplasty s… | 2010 |
| * | K171010 | Latitude EV Total Elbow ArthroplastySummary page 4…JDC Predicate Device Information Predicate: LATITUDE EV™ Total Elbow Arthroplasty (LATITUDE™ Elbow Prosthesis) 510(k) Number: K100562, K171010 Reference Device: RHS 510(k) Number: K060438 Device Description The Latitude EV™ Total Elbow Arthroplasty system is… | 2017 |
| † | K060438 | RHS | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193247 | LATITUDE EV™ Total Elbow Arthroplasty | 2020 | 0 |
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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K193247 (Tornier, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K100562.
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. 2018, this device’s year, is highlighted.
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 Latitude EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.
The Latitude EV™ Total Elbow Arthroplasty system is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182461: LATITUDE EV Total Elbow Arthroplasty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182461
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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