510(k) · Cleared
ClearedModification to Tornier 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 May 16, 2003 as substantially equivalent to K973357 (Zimmer, Inc., 1998) and 3 other predicates after a 29-day review. Its family tree reaches back 2 generations to 1989. 7 later devices descend from it.
- Decided
- May 16, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- JDB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K883665 (1989). 5 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK883665 Coonrad Iii Total ElbowZimmer, Inc. · 1989
- 1 generation backK973357 Coonrad/Morrey Total Elbow, New Hinge PinZimmer, Inc. · 1998 · Recalled
- This deviceK031218 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
- Descendant · 2 generations on · 1 of its ownK181362 TEMA Elbow SystemLima Corporate S.P.A. · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK182461 LATITUDE EV Total Elbow ArthroplastyTornier, Inc. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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
- K181362TEMA Elbow SystemLima Corporate S.P.A. · 2019 · 2 generations on1descendant
- K182461LATITUDE EV Total Elbow ArthroplastyTornier, Inc. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883665 | Coonrad Iii Total Elbow | Zimmer, Inc. | 1989 | — |
| −1 | K973357 | Coonrad/Morrey Total Elbow, New Hinge Pin | Zimmer, Inc. | 1998 | 1 |
| 0 (this device) | 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 | — |
| +2 | K181362 | TEMA Elbow System | Lima Corporate S.P.A. | 2019 | 1 |
| +2 | K182461 | LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K973357 | Coonrad/Morrey Total Elbow, New Hinge PinSummary page 1…ented prosthesis 9 888.3150 Elbow joint metaumetal or metaVpolymer constrained cemented prosthesis 5) Equivalent / Predicate device Coonrad / Morrey Total Elbow, Zimmer (K973357) Sorbie - Questor Elbow System, Wright 6 9 5 5 0 9 9 ) Tornier Total Elbow Prosthesis, Tornier (KO00003 and KO 11567)… | 1998 |
| * | K955099 | Sorbie Total Elbow System | 1996 |
| * | K000003 | Tornier Total Elbow Prosthesis | 2000 |
| * | K011567 | Tornier Total Elbow Prosthesis | 2001 |
What descends from it? (7)
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)
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 14 years and passes through 2 companies; a new generation was cleared every 9.1 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K070787 (Tornier, 2007) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K973357.
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 Tornier 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 deformities; revision
procedures where other treatments or device have failed; treatment of fractures
that are unmanageable using other techniques.
The Tornier Total Elbow Prosthesis is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031218: Modification to 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/K031218
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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