|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||ZIMMER NEXGEN LPS-FLEX MOBILE/LPS-MOBILE BEARING KNEE SYSTEMS|
|Classification Name||prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing|
|Supplement Type|| Special Supplement|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for: 1) adding a verification step to use a poke-yoke fixture to sort product during manufacturing; and 2) adding a step to verify the spiralock thread function.