510(k) · Cleared
ClearedCapitello-Condylar Total Elbow Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · JDB Prosthesis, Elbow, Semi-Constrained, Cemented
Cleared on Nov 6, 1998 after a 59-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Nov 6, 1998
- Review
- 59 days
- Class
- Class II
- Product code
- JDB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK983141 Capitello-Condylar Total Elbow ProsthesisJohnson & Johnson Professionals, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK992656 Depuy Total Elbow SystemDePuy Orthopaedics, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 0 of its ownK060696 Acclaim Total Elbow SystemDePuy Orthopaedics, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK042664 LPS Upper ExtremityDepuy, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983141 | Capitello-Condylar Total Elbow Prosthesis | Johnson & Johnson Professionals, Inc. | 1998 | — |
| +1 | K992656 | Depuy Total Elbow System | DePuy Orthopaedics, Inc. | 1999 | 2 |
| +2 | K060696 | Acclaim Total Elbow System | DePuy Orthopaedics, Inc. | 2006 | — |
| +2 | K042664 | LPS Upper Extremity | Depuy, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 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 JDB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JDB device
- #1 K222807 TEMA Elbow system - Line extensionscore 4.0 · 7 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | — | Pre-Amendment Capitello-Condylar Elbow System Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992656 | Depuy Total Elbow System | 1999 | 2 |
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?
- Of its descendants, K992656 (DePuy Orthopaedics, Inc., 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JDB devicesJDB Prosthesis, Elbow, Semi-Constrained, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDB
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JDB
Too few JDB 510(k)s in any year since 2007 to give a median.
Recalls per year · JDB
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDB
38in 2025
MAUDE reports naming product code JDB, 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 | 2 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 2 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 6 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 44 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 1 | — | 0 | 26 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 0 | — | 0 | 31 |
| 2020 | 1 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 1 | — | 0 | 58 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 1 | 163 |
| 2025 | 0 | — | 0 | 38 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Capitello-Condylar Total Elbow Prosthesis is indicated for arthroplasty of the elbow in patients suffering from rheumatoid arthritis with intractable elbow pain, limited motion, and radiographically identifiable destruction, with relative preservation of bony stock. It is also indicated for use in certain older post-traumatic or osteoarthritic patients where a relatively low activity level is anticipated. This device is intended for cemented use.
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/K983141 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983141: Capitello-Condylar Total Elbow Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983141
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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