510(k) · Cleared
Recalled · Class II · 2019Coonrad/Morrey Total Elbow. Model 32-8105 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · JDC Prosthesis, Elbow, Constrained, Cemented
Cleared on Jul 25, 2000 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled 10 times.
- Decided
- Jul 25, 2000
- Review
- 26 days
- Class
- Class II
- Product code
- JDC
- Recalls
- 10
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK001989 Coonrad/Morrey Total Elbow. Model 32-8105 SeriesZimmer, Inc. · 2000
- Descendant · cites it directly · 8 of its ownK053189 Coonrad/Morrey Total Elbow, Model 8105 SeriesZimmer, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 4 of its ownK171010 Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK123862 Zimmer Nexel Total ElbowZimmer, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK181362 TEMA Elbow SystemLima Corporate S.P.A. · 2019 · Recalled
- Descendant · 3 generations on · 1 of its ownK182461 LATITUDE EV Total Elbow ArthroplastyTornier, Inc. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K053189Coonrad/Morrey Total Elbow, Model 8105 SeriesZimmer, Inc. · 2005 · cites it directly8descendants
- K171010Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017 · 2 generations on4descendants
- K123862Zimmer Nexel Total ElbowZimmer, Inc. · 2013 · cites it directly4descendants
- K181362TEMA Elbow SystemLima Corporate S.P.A. · 2019 · cites it directly1descendant
- K182461LATITUDE EV Total Elbow ArthroplastyTornier, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001989 | Coonrad/Morrey Total Elbow. Model 32-8105 Series | Zimmer, Inc. | 2000 | — |
| +1 | K053189 | Coonrad/Morrey Total Elbow, Model 8105 Series | Zimmer, Inc. | 2005 | 2 |
| +2 | K171010 | Latitude EV Total Elbow Arthroplasty | Tornier, Inc. | 2017 | — |
| +1 | K123862 | Zimmer Nexel Total Elbow | Zimmer, Inc. | 2013 | — |
| +1 | K181362 | TEMA Elbow System | Lima Corporate S.P.A. | 2019 | 1 |
| +3 | K182461 | LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2019 | Class II | Z-1000-2020 | Under Investigation by firm | The lot contained two outer pins instead of one outer and one inner pin. |
| Oct 10, 2019 | Class II | Z-0301-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Jan 24, 2018 | Class II | Z-1239-2018 | Under Investigation by firm | One lot of humeral stem implants do not include the humeral bushing components. |
| Aug 16, 2016 | Class II | Z-2752-2016 | Process design | Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing. The missing bushing… |
| Nov 19, 2012 | Class II | Z-0538-2013 | Process change control | Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit . |
| Jan 30, 2009 | Not classified | Z-1053-2009 | Labeling design | The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone. |
| Jan 30, 2009 | Not classified | Z-1054-2009 | Labeling design | The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone. |
| Jan 30, 2009 | Not classified | Z-1057-2009 | Labeling design | The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone. |
| Jan 30, 2009 | Not classified | Z-1058-2009 | Labeling design | The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone. |
| Mar 16, 2004 | Not classified | Z-0767-04 | Other | Right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053189 (Zimmer, Inc., 2005) has gone furthest, with 8 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/K001989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K001989: Coonrad/Morrey Total Elbow. Model 32-8105 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K001989
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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