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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 System
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantZimmer, Inc.
P.O. Box 708
Warsaw, IN 46581
PMA NumberP060037
Supplement NumberS067
Date Received09/17/2020
Decision Date09/24/2020
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  
Replacement of the Prolong UHMWPE crosslinked material specification document, change in references of inspection methodology procedure from the firms internal document to ASTM standards, removal of Free Radical Level by Electron Spin Resonance requirement, and elimination of critical process parameters from the specification document as the ownership of the process is being transferred to a supplier and the supplier will be responsible to maintain these critical process parameters and process monitoring.
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