|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||NEXGEN COMPLETE KNEE SOLUTION|
|Classification Name||prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the nexgen fluted stem mobile tibial component, resulting in the nexgen minimally invasive solutions (mis) lps-mobile tibial component. Changes made to the nexgen fluted stem mobile tibial component include shortening the tibial baseplate stem and adding broad proximal fins, changing the outer profile radius of the baseplate edge from a variable radius to a constant radius, and adding an additional size (4-plus) to the current range of sizes (1 - 8).