510(k) · Cleared
Recalled · Class II · 2012Coonrad/Morrey Total Elbow, New Hinge Pin
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 Mar 2, 1998 as substantially equivalent to K883665 (Zimmer, Inc., 1989) after a 175-day review. Its family tree reaches back 1 generation to 1989. 10 later devices descend from it. It has been recalled once.
- Decided
- Mar 2, 1998
- Review
- 175 days
- Class
- Class II
- Product code
- JDC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K883665 (1989). 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK883665 Coonrad Iii Total ElbowZimmer, Inc. · 1989
- This deviceK973357 Coonrad/Morrey Total Elbow, New Hinge PinZimmer, Inc. · 1998
- Descendant · cites it directly · 7 of its ownK050848 Tornier Elbow ProsthesisTornier · 2005
- Descendant · cites it directly · 7 of its ownK031218 Modification to Tornier Total Elbow ProsthesisTornier · 2003
- Descendant · 2 generations on · 6 of its ownK070787 Latitude Elbow ProthesisTornier · 2007
- Descendant · 2 generations on · 5 of its ownK100562 Latitude Elbow ProsthesisTornier, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 4 of its ownK171010 Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K050848Tornier Elbow ProsthesisTornier · 2005 · cites it directly7descendants
- K031218Modification to Tornier Total Elbow ProsthesisTornier · 2003 · cites it directly7descendants
- K070787Latitude Elbow ProthesisTornier · 2007 · 2 generations on6descendants
- K100562Latitude Elbow ProsthesisTornier, Inc. · 2010 · 2 generations on5descendants
- K171010Latitude EV Total Elbow ArthroplastyTornier, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883665 | Coonrad Iii Total Elbow | Zimmer, Inc. | 1989 | — |
| 0 (this device) | K973357 | Coonrad/Morrey Total Elbow, New Hinge Pin | Zimmer, Inc. | 1998 | — |
| +1 | K050848 | Tornier Elbow Prosthesis | Tornier | 2005 | — |
| +1 | K031218 | Modification to Tornier Total Elbow Prosthesis | Tornier | 2003 | — |
| +2 | K070787 | Latitude Elbow Prothesis | Tornier | 2007 | — |
| +2 | K100562 | Latitude Elbow Prosthesis | Tornier, Inc. | 2010 | 2 |
| +3 | K171010 | Latitude EV Total Elbow Arthroplasty | Tornier, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K883665 | Coonrad Iii Total ElbowSummary page 2…Effectiveness Coonrad/Morrey Total Elbow, New Hinge Pin (Continued) Device Description The Coonrad/Morrey Total Elbow is closely based on the Coonrad III Total Elbow (K883665) cleared by FDA on February 3, 1989, with several exceptions. Intended Use The Coonrad/Morrey Total Elbow is indicated for: o P… | 1989 |
What descends from it? (10)
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 |
|---|---|---|---|---|
| Nov 19, 2012 | Class II | Z-0537-2013 | 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 . |
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?
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 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…
Read the full statement (127 words)
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
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. Patients 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973357: Coonrad/Morrey Total Elbow, New Hinge Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973357
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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