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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 NumberS092
Date Received11/19/2024
Decision Date12/12/2024
Product Code NJL 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
revision of device labeling to implement the following changes: 1) Addition of further information to Package Insert to provide detailed information of Implant material composition, and warning for carcinogenic, mutagenic and reprotoxic (CMR) substance, Intended Purpose, Intended Use, Patient Target Group, Intended Users, Expected Lifetime Statement, Expected Clinical Benefit, Patient Counseling information, and Disclosure of Residual Risks; 2) Information for Patient (IFP) will be created and be accessible to patients via Zimmer Biomet website, and 3) Patient Implant Card label will be provided with a device
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