510(k) · Cleared
ClearedZimmer Nexel Total Elbow Ulnar Cement Diverter
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 Apr 23, 2015 as substantially equivalent to K123862 (Zimmer, Inc., 2013) after a 56-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Apr 23, 2015
- Review
- 56 days
- Class
- Class II
- Product code
- JDC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001989 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK001989 Coonrad/Morrey Total Elbow. Model 32-8105 SeriesZimmer, Inc. · 2000 · Recalled
- 2 generations backK053189 Coonrad/Morrey Total Elbow, Model 8105 SeriesZimmer, Inc. · 2005 · Recalled
- 1 generation backK123862 Zimmer Nexel Total ElbowZimmer, Inc. · 2013
- This deviceK150501 Zimmer Nexel Total Elbow Ulnar Cement DiverterZimmer, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK181307 Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K181307Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001989 | Coonrad/Morrey Total Elbow. Model 32-8105 Series | Zimmer, Inc. | 2000 | 10 |
| −2 | K053189 | Coonrad/Morrey Total Elbow, Model 8105 Series | Zimmer, Inc. | 2005 | 2 |
| −1 | K123862 | Zimmer Nexel Total Elbow | Zimmer, Inc. | 2013 | — |
| 0 (this device) | K150501 | Zimmer Nexel Total Elbow Ulnar Cement Diverter | Zimmer, Inc. | 2015 | — |
| +1 | K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow | Zimmer, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K123862 | Zimmer Nexel Total ElbowSummary page 4…fication Panel: Orthopedics/87 Predicate Device(s): Zimmer® Nexel® Total Elbow, manufactured by Zimmer, Inc., K123862, cleared March 12, 2013. Purpose and Device Description: The Zimmer Nexel Total Elbow system includes a… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow | 2019 | 0 |
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 15 years and passes through 1 company; a new generation was cleared every 5.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K181307 (Zimmer, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K123862.
How does its category compare?
All JDC devicesJDC Prosthesis, Elbow, Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 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…
Read the full statement (103 words)
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/K150501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150501: Zimmer Nexel Total Elbow Ulnar Cement Diverter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150501
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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