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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 NumberS086
Date Received12/05/2023
Decision Date12/22/2023
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for adding ‘Temperature of the nitric acid’ and ‘final rinse tank conductivity’ to be monitored for NexGen® LPS-Flex / LPS-Mobile Bearing Knee and tightening ‘nitric acid upgrade time’ in a nitric acid bioburden reduction process for UHMWPE components of NexGen® LPS-Flex / LPS-Mobile Bearing Knee.
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