510(k) · Cleared
ClearedAnatomic Modular Knee (Amk) Posterior Stabilized
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 Aug 30, 1993 after a 54-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Aug 30, 1993
- Review
- 54 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK933304 Anatomic Modular Knee (Amk) Posterior StabilizedDepuy, Inc. · 1993
- Descendant · cites it directly · 2 of its ownK040413 Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018…Cordis Europa, N.V. · 2004
- Descendant · 2 generations on · 1 of its ownK053454 RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006
- Descendant · 3 generations on · 0 of its ownK063481 Modification to RX Herculink Elite Biliary Stent SystemAbbott Vascular, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See all- K040413Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery SystemCordis Europa, N.V. · 2004 · cites it directly2descendants
- K053454RX Herculink Elite Biliary Stent SystemGuidant Corporation · 2006 · 2 generations on1descendant
- K063481Modification to RX Herculink Elite Biliary Stent SystemAbbott Vascular, Inc. · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933304 | Anatomic Modular Knee (Amk) Posterior Stabilized | Depuy, Inc. | 1993 | — |
| +1 | K040413 | Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System | Cordis Europa, N.V. | 2004 | — |
| +2 | K053454 | RX Herculink Elite Biliary Stent System | Guidant Corporation | 2006 | — |
| +3 | K063481 | Modification to RX Herculink Elite Biliary Stent System | Abbott Vascular, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040413 | Cordis Palmaz Blue Transhepatic Biliary Stent on Slalom .018 Delivery System | 2004 | 2 |
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, K040413 (Cordis Europa, N.V., 2004) has gone furthest, with 2 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/K933304 · printed Nov 5, 2026
Cite this page
510(k) Report. “K933304: Anatomic Modular Knee (Amk) Posterior Stabilized.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K933304
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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