510(k) · Cleared
ClearedZimmer Nexel Total Elbow, Connrad/Morrey Total Elbow
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 Jan 28, 2019 as substantially equivalent to K150501 (Zimmer, Inc., 2015) and 4 other predicates after a 256-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Jan 28, 2019
- Review
- 256 days
- Class
- Class II
- Product code
- JDC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K001989 (2000). 9 ancestors in all, the oldest K883665 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK001989 Coonrad/Morrey Total Elbow. Model 32-8105 SeriesZimmer, Inc. · 2000 · Recalled
- 3 generations backK053189 Coonrad/Morrey Total Elbow, Model 8105 SeriesZimmer, Inc. · 2005 · Recalled
- 2 generations backK123862 Zimmer Nexel Total ElbowZimmer, Inc. · 2013
- 1 generation backK150501 Zimmer Nexel Total Elbow Ulnar Cement DiverterZimmer, Inc. · 2015
- This deviceK181307 Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001989 | Coonrad/Morrey Total Elbow. Model 32-8105 Series | Zimmer, Inc. | 2000 | 10 |
| −3 | K053189 | Coonrad/Morrey Total Elbow, Model 8105 Series | Zimmer, Inc. | 2005 | 2 |
| −2 | K123862 | Zimmer Nexel Total Elbow | Zimmer, Inc. | 2013 | — |
| −1 | K150501 | Zimmer Nexel Total Elbow Ulnar Cement Diverter | Zimmer, Inc. | 2015 | — |
| 0 (this device) | K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow | Zimmer, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K150501 | Zimmer Nexel Total Elbow Ulnar Cement DiverterSummary page 5…510(k) Number Zimmer Nexel Total Elbow K150501 Coonrad/Morrey Total Elbow K053189 Coonrad/Morrey Total Elbow… | 2015 |
| * | K053189 | Coonrad/Morrey Total Elbow, Model 8105 SeriesSummary page 5…Number Zimmer Nexel Total Elbow K150501 Coonrad/Morrey Total Elbow K053189 Coonrad/Morrey Total Elbow K040389 Coonrad/Morrey Total Elbow… | 2005 |
| * | K040389 | Coonrad/Morrey Elbow Cement RestrictorSummary page 5…K150501 Coonrad/Morrey Total Elbow K053189 Coonrad/Morrey Total Elbow K040389 Coonrad/Morrey Total Elbow K001989 Coonrad/Morrey Total Elbow… | 2004 |
| * | K001989 | Coonrad/Morrey Total Elbow. Model 32-8105 SeriesSummary page 5…K053189 Coonrad/Morrey Total Elbow K040389 Coonrad/Morrey Total Elbow K001989 Coonrad/Morrey Total Elbow K973357 Purpose and Device Description: The C… | 2000 |
| * | K973357 | Coonrad/Morrey Total Elbow, New Hinge PinSummary page 5…K040389 Coonrad/Morrey Total Elbow K001989 Coonrad/Morrey Total Elbow K973357 Purpose and Device Description: The Coonrad/Morrey Total Elbow and Zimmer Nexel Total Elbow are total elbow… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 1 company; a new generation was cleared every 5.4 years on median.
- 6 of the 9 ancestors have a recall of any class.
How does its category compare?
All JDC devicesJDC Prosthesis, Elbow, Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 (235 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 include:
- Elbow joint destruction which significantly compromises the activities of daily living
- Post-traumatic lesions or bone loss contributing to elbow instability
- Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis
- Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain
- Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
- Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
- Revision arthroplasty
Caution: This device is intended for cemented use only.
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/K181307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181307: Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181307
Report an extraction error
Are you the manufacturer?
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