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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 NumberS061
Date Received07/11/2019
Decision Date08/07/2019
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  
Removal of the cytotoxicity test requirement from the routine process monitoring of the final cleaning process for the NexGen®Complete Knee Solution, Legacy® Knee – Posterior Stabilized (LPS) and the LPS-Flex Mobile Bearing Knee femoral components, at the Shannon, Ireland facility.
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