510(k) · Cleared
ClearedZimmer Nexel 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 Mar 12, 2013 as substantially equivalent to K001989 (Zimmer, Inc., 2000) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it.
- Decided
- Mar 12, 2013
- Review
- 88 days
- Class
- Class II
- Product code
- JDC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001989 (2000). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001989 Coonrad/Morrey Total Elbow. Model 32-8105 SeriesZimmer, Inc. · 2000 · Recalled
- 1 generation backK053189 Coonrad/Morrey Total Elbow, Model 8105 SeriesZimmer, Inc. · 2005 · Recalled
- This deviceK123862 Zimmer Nexel Total ElbowZimmer, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK181362 TEMA Elbow SystemLima Corporate S.P.A. · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK150501 Zimmer Nexel Total Elbow Ulnar Cement DiverterZimmer, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK222807 TEMA Elbow system - Line extensionLima Corporate S.P.A. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK181307 Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K181362TEMA Elbow SystemLima Corporate S.P.A. · 2019 · cites it directly1descendant
- K150501Zimmer Nexel Total Elbow Ulnar Cement DiverterZimmer, Inc. · 2015 · cites it directly1descendant
- K222807TEMA Elbow system - Line extensionLima Corporate S.P.A. · 2022 · 2 generations on0descendants
- K181307Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001989 | Coonrad/Morrey Total Elbow. Model 32-8105 Series | Zimmer, Inc. | 2000 | 10 |
| −1 | K053189 | Coonrad/Morrey Total Elbow, Model 8105 Series | Zimmer, Inc. | 2005 | 2 |
| 0 (this device) | K123862 | Zimmer Nexel Total Elbow | Zimmer, Inc. | 2013 | — |
| +1 | K181362 | TEMA Elbow System | Lima Corporate S.P.A. | 2019 | 1 |
| +1 | K150501 | Zimmer Nexel Total Elbow Ulnar Cement Diverter | Zimmer, Inc. | 2015 | — |
| +2 | K222807 | TEMA Elbow system - Line extension | Lima Corporate S.P.A. | 2022 | 1 |
| +2 | K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow | Zimmer, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 2 | 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? (2)
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…JDC - Prosthesis, Elbow, Constrained, Cemented Predicate Device: Coonrad/Morrey Total Elbow, manufactured by Zimmer, K001989 cleared 25 July 2000 Coonrad/Morrey Total Elbow, manufactured by Zimmer,… | 2000 |
| * | K053189 | Coonrad/Morrey Total Elbow, Model 8105 SeriesSummary page 1…K001989 cleared 25 July 2000 Coonrad/Morrey Total Elbow, manufactured by Zimmer, K053 189, cleared 9 December 2005 Device Description: The Zimmer Nexel total Elbow is a total elbow prosthesis… | 2005 |
What descends from it? (4)
2 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)
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 13 years and passes through 1 company; a new generation was cleared every 7.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K181362 (Lima Corporate S.P.A., 2019) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K001989.
How does its category compare?
All JDC devicesJDC Prosthesis, Elbow, Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 ofjoint or soft tissue damage…
Read the full statement (102 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 ofjoint 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 as stated in the FDA summary.
https://510kreport.com/device/K123862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123862: Zimmer Nexel 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/K123862
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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