510(k) · Cleared
ClearedDuracon Posterior Femoral Spacer
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 Nov 14, 1996 as substantially equivalent to K915512 (Pfizer Hospital Products Group, Inc., 1992) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Nov 14, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904208 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK904208 Kinemax Superstabilizer Total Knee SystemHowmedica Corp. · 1991 · Recalled
- This deviceK963242 Duracon Posterior Femoral SpacerHowmedica Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904208 | Kinemax Superstabilizer Total Knee System | Howmedica Corp. | 1991 | 1 |
| 0 (this device) | K963242 | Duracon Posterior Femoral Spacer | Howmedica Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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? (5)
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 |
|---|---|---|---|
| * | K915512 | Duracon Total Knee System Tibial ComponentsSummary page 1…Spacer is substantially equivalent to several other legally marketed devices. Examples of these are listed below: 1. Duracon® Total Knee System Distal Femoral Spacers (K915512) - Howmedica 2. Duracon® Total Knee System Distal-Posterior Femoral Spacers (K915512) - Howmedica 3. Kinemax® Plus Superstabilize… | 1992 |
| * | K904208 | Kinemax Superstabilizer Total Knee SystemSummary page 1…medica 2. Duracon® Total Knee System Distal-Posterior Femoral Spacers (K915512) - Howmedica 3. Kinemax® Plus Superstabilizer Total Knee System Femoral Posterior Spacers (K904208) - Howmedica 4. Series 7000 Total Knee System Femoral Posterior Spacers - Osteonics Corporation 5. Genesis Total Knee System Fe… | 1991 |
| * | — | Series 7000 Total Knee System Femoral Posterior Spacers Named without a submission number | |
| * | — | Genesis Total Knee System Femoral Posterior Spacers Named without a submission number | |
| * | — | Coordinate Total Knee System Femoral Posterior Spacers Named without a submission number | |
| † | K910235 | Pca MTK II Total Knee System | 1991 |
| † | K920034 | Duracon Modular Femoral Component and Femoral Spac | 1992 |
| † | K932070 | Duracon Stabilizer Femoral Component and Insert | 1995 |
| † | K954138 | Duracon Monolithic Stabilizer Femoral Component | 1995 |
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?
- 2 of the 2 ancestors have a recall of any class.
- 2 other devices also cite its predicate K915512.
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® Femoral Posterior Spacer is intended to be used with the femoral components of the Duracon® Total Knee System (reference premarket notifications K910235, K920034, K932070, and K954138) to augment bone loss in the area of the posterior condyle of the femur. Posterior bone loss that requires augmentation by spacers may be noted in primary or revision total knee arthroplasty cases.
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/K963242 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963242: Duracon Posterior Femoral Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963242
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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