510(k) · Cleared
Recalled · 2009Coonrad/Morrey Total Elbow, Model 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 Dec 9, 2005 as substantially equivalent to K001989 (Zimmer, Inc., 2000) after a 24-day review. Its family tree reaches back 1 generation to 2000. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 9, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- JDC
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001989 (2000). 8 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK001989 Coonrad/Morrey Total Elbow. Model 32-8105 SeriesZimmer, Inc. · 2000 · Recalled
- This deviceK053189 Coonrad/Morrey Total Elbow, Model 8105 SeriesZimmer, Inc. · 2005
- Descendant · cites it directly · 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 · 2 generations on · 1 of its ownK182461 LATITUDE EV Total Elbow ArthroplastyTornier, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK150501 Zimmer Nexel Total Elbow Ulnar Cement DiverterZimmer, Inc. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K171010Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017 · cites it directly4descendants
- 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 · 2 generations on1descendant
- K150501Zimmer Nexel Total Elbow Ulnar Cement DiverterZimmer, Inc. · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001989 | Coonrad/Morrey Total Elbow. Model 32-8105 Series | Zimmer, Inc. | 2000 | 10 |
| 0 (this device) | K053189 | Coonrad/Morrey Total Elbow, Model 8105 Series | Zimmer, Inc. | 2005 | — |
| +1 | 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 |
| +2 | K182461 | LATITUDE EV Total Elbow Arthroplasty | Tornier, Inc. | 2018 | — |
| +2 | K150501 | Zimmer Nexel Total Elbow Ulnar Cement Diverter | Zimmer, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (1)
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 |
|---|---|---|---|
| * | K001989 | Coonrad/Morrey Total Elbow. Model 32-8105 SeriesSummary page 1…ad/MNorrev Total E11bow. manuIfactured by Zimmer, Inc., K<001989, cleared .July 25. 2000 Dkevice Description: The Coonrad Morrey Total $Ilbow is a total elbow prosthesis desi gned tor… | 2000 |
What descends from it? (8)
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 |
|---|---|---|---|---|
| Jan 30, 2009 | Not classified | Z-1056-2009 | 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-1055-2009 | Labeling design | The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 | — |
What is it indicated for?
Indications include: post-traumatic lesions or bone loss contributing to elbow instability; ankylosed joints, especially in cases of bilateral ankylosis from causes other than sepsis; advanced rheumatoid or degenerative arthritis with incapacitating pain; revision arthroplasty, and instability or loss of motion when the degree of joint damage precludes less radical procedures. The candidate for total elbow arthroplasty should exhibit joint destruction…
Read the full statement (132 words)
Indications include: post-traumatic lesions or bone loss contributing to elbow instability; ankylosed joints, especially in cases of bilateral ankylosis from causes other than sepsis; advanced rheumatoid or degenerative arthritis with incapacitating pain; revision arthroplasty, and instability or loss of motion when the degree of joint damage precludes less radical procedures.
The candidate for total elbow arthroplasty should exhibit joint destruction which significantly compromises the activities of daily living. Patient with single joint involvement (generally those with traumatic or degenerative arthritis) or significant lower extremity disability which require walking aids are less amenable to treatment than patients with advanced and predominantly upper extremity involvement. If possible, elbow replacement should be done after hip or knee surgery to avoid excessive stress to the prosthesis required by crutch walking during total hip or knee rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053189 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053189: Coonrad/Morrey Total Elbow, Model 8105 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053189
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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