510(k) · Cleared
ClearedDepuy Amk Porous Coated CRX Tibial Tray (1988-20/28-000 and 1988-20/28-501)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jun 18, 1996 after a 69-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jun 18, 1996
- Review
- 69 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK961379 Depuy Amk Porous Coated CRX Tibial Tray (1988-20/28-000 and…Depuy, Inc. · 1996
- 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 · 3 generations on · 0 of its ownK200765 Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK003026 PFC Sigma Lugged Tibial TrayDePuy Orthopaedics, Inc. · 2001
Most influential descendants
Showing 4 of 4 · See all- 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
- K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd. · 2021 · 3 generations on0descendants
- K003026PFC Sigma Lugged Tibial TrayDePuy Orthopaedics, Inc. · 2001 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961379 | Depuy Amk Porous Coated CRX Tibial Tray (1988-20/28-000 and 1988-20/28-501) | Depuy, Inc. | 1996 | — |
| +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 | — |
| +3 | K200765 | Genius / Genuin Total Knee System | Biorad Medisys Pvt, Ltd. | 2021 | — |
| +2 | K003026 | PFC Sigma Lugged Tibial Tray | DePuy Orthopaedics, Inc. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | — | DePuy AMK Cemented CRX Tibial Tray Named without a submission number | |
| * | — | DePuy Synatomic Variable Fit Tibial Plateau Named without a submission number | |
| * | — | Howmedica PCA Modular Stemmed Tibial Baseplate Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991106 | P.F.C. Sigma Porous Modular Keel Tibial Tray | 1999 | 3 |
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, K991106 (DePuy Orthopaedics, Inc., 1999) has gone furthest, with 3 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 DePuy AMK Porous Coated CRX Tibial Tray is intended to be used as the tibial component in cemented total knee arthroplasty.
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/K961379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961379: Depuy Amk Porous Coated CRX Tibial Tray (1988-20/28-000 and 1988-20/28-501).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961379
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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