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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNexGen® LPS-Flex LPS-Mobile Bearing Knee
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZimmer, Inc.
P.O. Box 708
Warsaw, IN 46581
PMA NumberP060037
Supplement NumberS091
Date Received06/27/2024
Decision Date07/05/2024
Product Code NJL 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
two changes to the NexGen® LPS-Flex/LPS Mobile Bearing Knee System Femoral components manufactured at the Zimmer Orthopedics Manufacturing Limited, Shannon, Ireland facility. Change One includes changing the order of the manufacturing process flow steps, to introduce additional in-process cleaning step, and to introduce anewer model of the laser etch equipment and fixture for the NexGen® LPS-Flex/LPS Mobile Bearing Knee System Femoral components. Change Two includes the introduction of Haas Multigrind Grind equipment and Intec Robotic Polisher equipment for the Grind and Polish operations of the NexGen® LPS-Flex/LPS Mobile Bearing Knee System Femoral components
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