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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 NumberS062
Date Received09/26/2019
Decision Date10/24/2019
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  
Change in the density range of gamma sterilization from 0.09 to 0.2 g/cm3 to 0.05 to 0.15 g/cm3. The density range is used in the gamma sterilization of NexGen® LPSFlex/LPS-Mobile Bearing Knee manufactured at Zimmer Orthopedics Manufacturing Limited (ZOML) Shannon Ireland facility.
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