510(k) · Cleared
ClearedDuracon Inset Patella with Central Peg
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 Jul 5, 1996 after a 78-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jul 5, 1996
- Review
- 78 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK961482 Duracon Inset Patella with Central PegHowmedica Corp. · 1996
- Descendant · cites it directly · 1 of its ownK971789 Implex Continuum Porous PatellarImplex Corp. · 1997
- Descendant · cites it directly · 0 of its ownK993692 Duracon Inset Patella, 25MMHowmedica Osteonics Corp. · 1999
- Descendant · 2 generations on · 0 of its ownK983835 Implex Continuum Patella-Revision Hedrocel PatellaImplex Corp. · 1999
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) | K961482 | Duracon Inset Patella with Central Peg | Howmedica Corp. | 1996 | — |
| +1 | K971789 | Implex Continuum Porous Patellar | Implex Corp. | 1997 | — |
| +1 | K993692 | Duracon Inset Patella, 25MM | Howmedica Osteonics Corp. | 1999 | — |
| +2 | K983835 | Implex Continuum Patella-Revision Hedrocel Patella | Implex Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 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 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? (6)
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® Recessed Patella Named without a submission number | |
| * | — | Duracon® All-Poly Patella Named without a submission number | |
| * | — | Genesis Biconvex Patella Named without a submission number | |
| * | — | Oomnifit All-Polyethylene Patella Named without a submission number | |
| * | — | Miller-Galante II All-Polyethylene Patella Named without a submission number | |
| * | — | Kinematic® II All-Polyethylene Patella Named without a submission number |
What descends from it? (3)
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?
- Of its descendants, K971789 (Implex Corp., 1997) has gone furthest, with 1 descendant of its own.
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?
This device, an all-polyethylene concentric dome patella, is intended to be used with the femoral and tibial components of the Duracon® and P.C.A.® MTK II components as a total knee system. This component is intended to be used in the primary and/or revision replacement of the articular surface of the patella.
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/K961482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961482: Duracon Inset Patella with Central Peg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961482
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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