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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 MOBILE AND 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 NumberS048
Date Received11/23/2016
Decision Date01/12/2017
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  
Introduce an alternative manufacturing material (i.e., liquid penetrant) that is used during the Liquid Penetrant Inspection process of the NexGen Complete Knee Solution, Legacy Knee – Posterior Stabilized (LPS), LPS-Flex Mobile Bearing Knee metal femoral components at the Shannon Ireland facility.
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