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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 NumberS056
Date Received04/23/2018
Decision Date05/23/2018
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  
Addition of IMR Laboratories, located at Lansing, New York, USA and Louisville, Kentucky, USA as approved suppliers to complete cleaning residual analysis for validations and process monitoring of the final cleaning process for the NexGen LPS-Flex/LPS-Mobile Bearing Knee System components manufactured in Warsaw, Indiana, USA and Shannon, Ireland facilities.
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