510(k) · Cleared
Recalled · 2012Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining (CR) Articular Surface Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Mar 19, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 205 later devices descend from it. It has been recalled 65 times.
- Decided
- Mar 19, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 65
- Predicates
- 0
205 later devices descend from it, 3 citing it directly.
- This deviceK003910 Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate…Zimmer, Inc. · 2001
- Descendant · cites it directly · 203 of its ownK013991 Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR)…Zimmer, Inc. · 2001
- Descendant · 2 generations on · 123 of its ownK070214 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 117 of its ownK073286 Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 96 of its ownK113369 Zimmer Persona Knee SystemZimmer, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 79 of its ownK060722 Nexgen Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing…Zimmer, Inc. · 2006
Showing 5 of 205 descendants. See all descendants
Descendants cleared per year
2001high 23 (2021) · low 0 (2002)2026
Most influential descendants
Showing 5 of 205 · See all- K013991Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface…Zimmer, Inc. · 2001 · cites it directly203descendants
- K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2007 · 2 generations on123descendants
- K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc. · 2008 · 3 generations on117descendants
- K113369Zimmer Persona Knee SystemZimmer, Inc. · 2012 · 3 generations on96descendants
- K060722Nexgen Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface…Zimmer, Inc. · 2006 · 2 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003910 | Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining… | Zimmer, Inc. | 2001 | — |
| +1 | K013991 | Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular… | Zimmer, Inc. | 2001 | — |
| +2 | K070214 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2007 | 63 |
| +3 | K073286 | Gender Solutions Natural-Knee Flex System | Zimmer, Inc. | 2008 | 5 |
| +3 | K113369 | Zimmer Persona Knee System | Zimmer, Inc. | 2012 | 39 |
| +2 | K060722 | Nexgen Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular… | Zimmer, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 9 | 0 |
| 2012 | 13 | 0 |
| 2013 | 12 | 0 |
| 2014 | 14 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 7 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 15 | 0 |
| 2021 | 23 | 0 |
| 2022 | 11 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 17 | 0 |
| 2026 | 16 | 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? (205)
See all 2053 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 |
|---|---|---|---|---|
| Feb 24, 2012 | Not classified | Z-1609-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1611-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1589-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1548-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1583-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1557-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1599-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1568-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1550-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1574-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1556-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1591-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1604-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1569-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1606-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1561-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1594-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1563-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1554-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1572-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1558-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1547-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1577-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1598-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1585-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1566-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1564-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1603-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1593-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1601-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1608-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1596-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1588-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1552-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1549-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1605-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1582-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1590-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1610-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1570-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1584-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1597-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1607-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1578-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1600-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1555-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1587-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1579-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1571-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
| Feb 24, 2012 | Not classified | Z-1559-2012 | Labeling design | Zimmer has received 5 complaints where a NexGen CR micro articular surface was used with a standard CR femur, even though the compatibility chart and product labeling indicates that these components are NOT compatible. Investigation… |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013991 (Zimmer, Inc., 2001) has gone furthest, with 203 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
2007high 33 (2012) · low 11 (2009)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
2007high 168 (2009) · low 55 (2025)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
2007high 109 (2009) · low 2 (2020)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
2007high 14,987 (2019) · low 1,305 (2007)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/K003910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003910: Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining (CR) Articular Surface Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003910
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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