510(k) · Cleared
Recalled · 2005Depuy Total Elbow System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · JDC Prosthesis, Elbow, Constrained, Cemented
Cleared on Nov 5, 1999 as substantially equivalent to K872084 (Depuy, Inc., 1987) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1987. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 5, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- JDC
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K872084 (1987). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK872084 Porocoat Mark II Total ElbowDepuy, Inc. · 1987
- This deviceK992656 Depuy Total Elbow SystemDePuy Orthopaedics, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK060696 Acclaim Total Elbow SystemDePuy Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK042664 LPS Upper ExtremityDepuy, Inc. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872084 | Porocoat Mark II Total Elbow | Depuy, Inc. | 1987 | — |
| 0 (this device) | K992656 | Depuy Total Elbow System | DePuy Orthopaedics, Inc. | 1999 | — |
| +1 | K060696 | Acclaim Total Elbow System | DePuy Orthopaedics, Inc. | 2006 | — |
| +1 | K042664 | LPS Upper Extremity | Depuy, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K872084 | Porocoat Mark II Total ElbowSummary page 2…he DePuy Total Elbow System is substantiated by its similarity in indications for use, design, materials, sterilization and packaging to the current DePuy Mark II Elbow (K872084) and the Capitello-Condylar Total Elbow (K983141). The determination of substantial equivalence for this device was based on a d… | 1987 |
| * | K983141 | Capitello-Condylar Total Elbow ProsthesisSummary page 2…ts similarity in indications for use, design, materials, sterilization and packaging to the current DePuy Mark II Elbow (K872084) and the Capitello-Condylar Total Elbow (K983141). The determination of substantial equivalence for this device was based on a detailed device description, and conformance with… | 1998 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2005 | Not classified | Z-0531-06 | Other | The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary. |
| Nov 8, 2005 | Not classified | Z-0530-06 | Other | The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary. |
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?
The DePuy Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, rheumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components. Total Elbow replacement may be considered for younger patients, if, in the opinion of the…
Read the full statement (137 words)
The DePuy Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, rheumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components.
Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient , and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives.
The DePuy Total Elbow System 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/K992656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992656: Depuy Total Elbow System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992656
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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