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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 46581-0708
PMA NumberP060037
Supplement NumberS076
Date Received12/10/2021
Decision Date01/05/2022
Product Code NJL 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Reduction in the number of biological indicators (BIs) for performance requalification and routine monitoring for hydrogen peroxide (VHP) gas plasma sterilization of their subject device, NexGen® LPS Flex/LPS Mobile Bearing Knee System, Cross-linked Polyethylene Prolong Articular Surface.
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