510(k) · Cleared
Recalled · Class II · 2025Latitude Elbow Prosthesis
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 Jun 29, 2010 as substantially equivalent to K000003 (Tornier, 2000) and 4 other predicates after a 120-day review. Its family tree reaches back 4 generations to 1989. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 29, 2010
- Review
- 120 days
- Class
- Class II
- Product code
- JDB
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 4 generations to K883665 (1989). 8 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK883665 Coonrad Iii Total ElbowZimmer, Inc. · 1989
- 3 generations backK973357 Coonrad/Morrey Total Elbow, New Hinge PinZimmer, Inc. · 1998 · Recalled
- 2 generations backK031218 Modification to Tornier Total Elbow ProsthesisTornier · 2003
- 1 generation backK070787 Latitude Elbow ProthesisTornier · 2007
- This deviceK100562 Latitude Elbow ProsthesisTornier, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK171010 Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK181362 TEMA Elbow SystemLima Corporate S.P.A. · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK182461 LATITUDE EV Total Elbow ArthroplastyTornier, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK222807 TEMA Elbow system - Line extensionLima Corporate S.P.A. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK193247 LATITUDE EV™ Total Elbow ArthroplastyTornier, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K171010Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017 · cites it directly4descendants
- K181362TEMA Elbow SystemLima Corporate S.P.A. · 2019 · cites it directly1descendant
- K182461LATITUDE EV Total Elbow ArthroplastyTornier, Inc. · 2018 · cites it directly1descendant
- K222807TEMA Elbow system - Line extensionLima Corporate S.P.A. · 2022 · 2 generations on0descendants
- K193247LATITUDE EV™ Total Elbow ArthroplastyTornier, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K883665 | Coonrad Iii Total Elbow | Zimmer, Inc. | 1989 | — |
| −3 | K973357 | Coonrad/Morrey Total Elbow, New Hinge Pin | Zimmer, Inc. | 1998 | 1 |
| −2 | K031218 | Modification to Tornier Total Elbow Prosthesis | Tornier | 2003 | — |
| −1 | K070787 | Latitude Elbow Prothesis | Tornier | 2007 | — |
| 0 (this device) | K100562 | Latitude Elbow Prosthesis | Tornier, Inc. | 2010 | — |
| +1 | K171010 | Latitude EV Total Elbow Arthroplasty | Tornier, Inc. | 2017 | — |
| +1 | K181362 | TEMA Elbow System | Lima Corporate S.P.A. | 2019 | 1 |
| +1 | K182461 | LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. | 2018 | — |
| +2 | K222807 | TEMA Elbow system - Line extension | Lima Corporate S.P.A. | 2022 | 1 |
| +2 | 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 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K000003 | Tornier Total Elbow ProsthesisSummary page 1…Class II Classification panel: Orthopedic Product code: JDB and JDC 5) Equivalent! Predicate device Tomier Latitud6 Elbow Prosthesis, K000003, KO 11567, K031218, K050848 and K070787 6) Device description Total Elbow replacement is used to treat a number o… | 2000 |
| * | K011567 | Tornier Total Elbow Prosthesis | 2001 |
| * | K031218 | Modification to Tornier Total Elbow ProsthesisSummary page 1…assification panel: Orthopedic Product code: JDB and JDC 5) Equivalent! Predicate device Tomier Latitud6 Elbow Prosthesis, K000003, KO 11567, K031218, K050848 and K070787 6) Device description Total Elbow replacement is used to treat a number of clinical conditio… | 2003 |
| * | K050848 | Tornier Elbow ProsthesisSummary page 1…ion panel: Orthopedic Product code: JDB and JDC 5) Equivalent! Predicate device Tomier Latitud6 Elbow Prosthesis, K000003, KO 11567, K031218, K050848 and K070787 6) Device description Total Elbow replacement is used to treat a number of clinical conditions such a… | 2005 |
| * | K070787 | Latitude Elbow ProthesisSummary page 1…Orthopedic Product code: JDB and JDC 5) Equivalent! Predicate device Tomier Latitud6 Elbow Prosthesis, K000003, KO 11567, K031218, K050848 and K070787 6) Device description Total Elbow replacement is used to treat a number of clinical conditions such as severe pai… | 2007 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 3, 2025 | Class II | Z-1651-2025 | Under Investigation by firm | A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm… |
| Jun 23, 2011 | Not classified | Z-3082-2011 | Process change control | Tornier has discovered that some models of the Tornier latitude Elbow Prosthesis (Small and Medium Humeral stems) were manufactured with a humeral screw that may not function as designed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K171010 (Tornier, Inc., 2017) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K000003.
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. 2010, 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 Tornier Inc. Latitude Elbow Prosthesis 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 osteoarthtitis 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 Tornier Inc. Latitude Elbow Prosthesis is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100562: Latitude 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/K100562
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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