510(k) · Cleared
Recalled · 2006P.F.C. Cruciate Retaining Knee System (Size 1.5)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 10, 1996 after a 70-day review. The FDA summary names its predicate without a number. 430 later devices descend from it. It has been recalled 7 times.
- Decided
- Jul 10, 1996
- Review
- 70 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 7
- Predicates
- 0
430 later devices descend from it, 13 citing it directly.
- This deviceK961685 P.F.C. Cruciate Retaining Knee System (Size 1.5)Johnson & Johnson Professionals, Inc. · 1996
- Descendant · cites it directly · 351 of its ownK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- Descendant · cites it directly · 324 of its ownK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- Descendant · 2 generations on · 158 of its ownK052472 Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005
- Descendant · cites it directly · 120 of its ownK062654 Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 115 of its ownK082500 Depuy Sigma CR-F Femoral ComponentDePuy Orthopaedics, Inc. · 2008
Showing 5 of 430 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 430 · See all- K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · cites it directly351descendants
- K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · cites it directly324descendants
- K052472Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005 · 2 generations on158descendants
- K062654Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc. · 2006 · cites it directly120descendants
- K082500Depuy Sigma CR-F Femoral ComponentDePuy Orthopaedics, Inc. · 2008 · cites it directly115descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961685 | P.F.C. Cruciate Retaining Knee System (Size 1.5) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| +1 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| +1 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| +2 | K052472 | Depuy Global Shoulder Crosslink Glenoid | DePuy Orthopaedics, Inc. | 2005 | — |
| +1 | K062654 | Depuy Sigma Cruciate Retaining Porocoat Femoral Components | DePuy Orthopaedics, Inc. | 2006 | — |
| +1 | K082500 | Depuy Sigma CR-F Femoral Component | DePuy Orthopaedics, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 6 | 0 |
| 2013 | 12 | 0 |
| 2014 | 12 | 0 |
| 2015 | 27 | 0 |
| 2016 | 19 | 0 |
| 2017 | 16 | 0 |
| 2018 | 16 | 0 |
| 2019 | 34 | 0 |
| 2020 | 34 | 0 |
| 2021 | 39 | 0 |
| 2022 | 30 | 0 |
| 2023 | 34 | 0 |
| 2024 | 40 | 0 |
| 2025 | 36 | 0 |
| 2026 | 38 | 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? (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 |
|---|---|---|---|
| * | — | P.F.C.® Cruciate Retaining Knee System Named without a submission number |
What descends from it? (430)
See all 43013 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033272 | Depuy Sigma Tibial Inserts | 2004 | 351 |
| K040166 | Depuy Sigma XLK Tibial Inserts | 2004 | 324 |
| K062654 | Depuy Sigma Cruciate Retaining Porocoat Femoral Components | 2006 | 120 |
| K082500 | Depuy Sigma CR-F Femoral Component | 2008 | 115 |
| K101433 | Depuy Attune Knee System | 2010 | 114 |
| K060192 | Apex Knee System | 2006 | 111 |
| K103756 | Depuy Attune Total Knee System | 2011 | 7 |
| K991106 | P.F.C. Sigma Porous Modular Keel Tibial Tray | 1999 | 3 |
| K182301 | PFC SIGMA Knee System | 2019 | 1 |
| K971652 | P.F.C. Sigma Inset Patella | 1997 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 14, 2006 | Not classified | Z-0057-2007 | Other | Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella. |
| May 26, 2005 | Not classified | Z-1317-05 | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. |
| May 26, 2005 | Not classified | Z-1315-05 | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. |
| May 26, 2005 | Not classified | Z-1319-05 | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. |
| May 26, 2005 | Not classified | Z-1316-05 | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. |
| May 26, 2005 | Not classified | Z-1320-05 | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. |
| May 26, 2005 | Not classified | Z-1318-05 | Other | An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033272 (DePuy Orthopaedics, Inc., 2004) has gone furthest, with 351 descendants 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?
The P.F.C.® Cruciate Retaining Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.
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/K961685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961685: P.F.C. Cruciate Retaining Knee System (Size 1.5).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961685
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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