510(k) · Cleared
Recalled · 2004P.F.C. Modular Total Knee System, Modular Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson International · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Nov 9, 1992 after a 103-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it. It has been recalled once.
- Decided
- Nov 9, 1992
- Review
- 103 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK923807 P.F.C. Modular Total Knee System, Modular PlusJohnson & Johnson International · 1992
- Descendant · cites it directly · 7 of its ownK984158 P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc. · 1999
- Descendant · 2 generations on · 3 of its ownK013906 HLS Noetos SystemTornier · 2002
- Descendant · cites it directly · 3 of its ownK991106 P.F.C. Sigma Porous Modular Keel Tibial TrayDePuy Orthopaedics, Inc. · 1999
- Descendant · 2 generations on · 1 of its ownK182301 PFC SIGMA Knee SystemDePuy Orthopaedics, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK094013 HLS Kneetec SystemTornier · 2011
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K984158P.F.C. Modular Plus Offset Tibial TrayDepuy, Inc. · 1999 · cites it directly7descendants
- K013906HLS Noetos SystemTornier · 2002 · 2 generations on3descendants
- K991106P.F.C. Sigma Porous Modular Keel Tibial TrayDePuy Orthopaedics, Inc. · 1999 · cites it directly3descendants
- K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc. · 2019 · 2 generations on1descendant
- K094013HLS Kneetec SystemTornier · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923807 | P.F.C. Modular Total Knee System, Modular Plus | Johnson & Johnson International | 1992 | — |
| +1 | K984158 | P.F.C. Modular Plus Offset Tibial Tray | Depuy, Inc. | 1999 | — |
| +2 | K013906 | HLS Noetos System | Tornier | 2002 | — |
| +1 | K991106 | P.F.C. Sigma Porous Modular Keel Tibial Tray | DePuy Orthopaedics, Inc. | 1999 | — |
| +2 | K182301 | PFC SIGMA Knee System | DePuy Orthopaedics, Inc. | 2019 | — |
| +2 | K094013 | HLS Kneetec System | Tornier | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2004 | Not classified | Z-1382-04 | Other | Screw size included in system was incorrect |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K984158 (Depuy, Inc., 1999) has gone furthest, with 7 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 | — |
https://510kreport.com/device/K923807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923807: P.F.C. Modular Total Knee System, Modular Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923807
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026