510(k) · Cleared
ClearedDuracon Inset Patella, 25MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Dec 2, 1999 as substantially equivalent to K961482 (Howmedica Corp., 1996) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Dec 2, 1999
- Review
- 30 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K961482 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK961482 Duracon Inset Patella with Central PegHowmedica Corp. · 1996
- This deviceK993692 Duracon Inset Patella, 25MMHowmedica Osteonics Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961482 | Duracon Inset Patella with Central Peg | Howmedica Corp. | 1996 | — |
| 0 (this device) | K993692 | Duracon Inset Patella, 25MM | Howmedica Osteonics Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 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? (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 |
|---|---|---|---|
| * | K961482 | Duracon Inset Patella with Central PegSummary page 1…ted prosthesis. Predicate Device Identification The Duracon Inset Patellar Component, in sizes 27, 29, 31, and 33mm, were determined Substantially Equivalent via 510(k) #K961482. They were then cleared in a Duration-stabilized version via K965173. This Special 510(k) covers an additional size component: 2… | 1996 |
| * | K965173 | Duration Stabilized Uhmwpe Knee ComponentsSummary page 1…llar Component, in sizes 27, 29, 31, and 33mm, were determined Substantially Equivalent via 510(k) #K961482. They were then cleared in a Duration-stabilized version via K965173. This Special 510(k) covers an additional size component: 25mm. Page i Duracon Inset Patellar Components: Additi… | 1997 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K961482.
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 subject devices are single use components, intended for cemented use only. They are intended for use in conjunction with associated Duracon femoral components as part of cemented total knee replacement surgery. Indications for use, in keeping with those of other commercially-available, Class II total knee devices, are as follows: Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis. Rheumatoid…
Read the full statement (95 words)
The subject devices are single use components, intended for cemented use only. They are intended for use in conjunction with associated Duracon femoral components as part of cemented total knee replacement surgery. Indications for use, in keeping with those of other commercially-available, Class II total knee devices, are as follows:
Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis.
Rheumatoid arthritis.
Correction of functional deformity.
Revision procedures where other treatments have failed.
Post-traumatic loss of knee joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy.
Irreparable fracture of the knee.
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/K993692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993692: Duracon Inset Patella, 25MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993692
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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