510(k) · Cleared
ClearedDuracon Conversion Metal Backed Patella
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Oct 21, 1997 after a 90-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 21, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Duracon® Metal Backed Patella - Howmedica Named without a submission number | |
| * | — | Duracon® All Polyethylene Patella - Howmedica Named without a submission number | |
| * | — | PCA Modular Knee Tibial Baseplates and Tibial Inserts - Howmedica Named without a submission number | |
| * | — | Series 7000 Metal Backed Patella - Osteonics Named without a submission number |
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.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
The Duracon® Conversion Metal Backed Patella is intended to be used with Duracon® femoral and tibial components as part of a total knee system. This total knee system is intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis. Specifically, this patellar component is intended to replace the articular surface of the natural…
Read the full statement (145 words)
The Duracon® Conversion Metal Backed Patella is intended to be used with Duracon® femoral and tibial components as part of a total knee system. This total knee system is intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis. Specifically, this patellar component is intended to replace the articular surface of the natural patella in primary or revision total knee scenarios.
The Duracon® Conversion Metal Backed Patella is intended to be a revisable component. The patellar component will be made available with the polyethylene insert assembled to the metal backing. Separate polyethylene patellar inserts will be made available so the physician can intraoperatively replace excessively worn polyethylene to a well-fixed metal patellar baseplate.
The Duracon® Conversion Metal Backed Patella is intended to be implanted using bone cement.
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/K972752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972752: Duracon Conversion Metal Backed Patella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972752
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026