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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 Mobile and LPS Mobile Bearing Knee System
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZimmer, Inc.
P.O. Box 708
Warsaw, IN 46581
PMA NumberP060037
Supplement NumberS065
Date Received06/16/2020
Decision Date07/13/2020
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  
Change in the gamma sterilization process monitoring for conventional ultra-high weight polyethylene (UHMWPE) articular surface components in NexGen LPS-Flex/LPS Mobile Bearing Knee System.
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