# K003910: Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining (CR) Articular Surface Components

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 19, 2001 after 90 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 65 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
205 later devices descend from it; 3 cite it directly.
0 of 206 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013991: Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface Components (2001), 203 descendants of its own
- K070214: Gender Solutions Natural-Knee Flex System (2007), 123 descendants of its own
- K073286: Gender Solutions Natural-Knee Flex System (2008), 117 descendants of its own
- K113369: Zimmer Persona Knee System (2012), 96 descendants of its own
- K060722: Nexgen Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface Component (2006), 79 descendants of its own

## Recalls of this device
- Feb 24, 2012 · Not classified · Z-1609-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1611-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1589-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1548-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1583-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1557-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1599-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1568-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1550-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1574-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1556-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1591-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1604-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1569-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1606-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1561-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1594-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1563-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1554-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1572-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1558-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1547-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1577-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1598-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1585-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1566-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1564-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1603-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1593-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1601-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1608-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1596-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1588-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1552-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1549-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1605-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1582-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1590-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1610-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1570-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1584-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1597-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1607-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1578-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1600-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1555-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1587-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1579-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1571-2012: 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 a
- Feb 24, 2012 · Not classified · Z-1559-2012: 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 a

Source page: https://510kreport.com/device/K003910
Methodology: https://510kreport.com/methodology