# K951185: Nexgen Complete Knee Solution 9MM Articular Surface

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 15, 1996 after 365 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.
85 later devices descend from it; 2 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MG II® Total Knee System: named in the summary without a submission number
- (no number) Insall/Burstein® II Modular Knee System: named in the summary without a submission number

## Most influential descendants
- K081023: Evolis Total Knee System (2008), 78 descendants of its own
- K090988: GMK Total Knee System (2009), 52 descendants of its own
- K102437: GMK Revision Knee System (2010), 34 descendants of its own
- K103170: GMK Revision Knee SC Liners (2011), 28 descendants of its own
- K113571: GMK Resufacing Patella Size 4 (2012), 23 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

## Indications for use
The device is intended to reduce or relieve pain and restore function and motion to the knee joint.

Source page: https://510kreport.com/device/K951185
Methodology: https://510kreport.com/methodology