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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.
 
DeviceLCS Total Knee System
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantDepuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw, IN 46581
PMA NumberP830055
Supplement NumberS259
Date Received10/28/2020
Decision Date11/27/2020
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  
Establish the SAFC St. Louis site as an additional supplier of AOX antioxidant solution to ensure continued availability of the AOX bar stock material, which is used in manufacture of the ATTUNE Revision CRS Rotating Platform Inserts, the ATTUNE CR Rotating Platform Inserts, the ATTUNE PS Rotating Platform Inserts, theSigma Rotating Platform AO Curved Tibial Inserts, and the Sigma Rotating Platform AO Stabilized Tibial Inserts at the DePuy Cork site; and of the LCS Complete RPS AOX Inserts, the LCS Complete RP AOX Inserts and the Sigma RPF AOX Inserts at the DePuy Raynham site.
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