Premarket Approval (PMA)

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.

• Device: LCS Total Knee System
• Generic Name: Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
• Applicant: Depuy, Inc.; P.O. Box 988; 700 Orthopaedic Dr.; Warsaw, IN 46581
• PMA Number: P830055
• Supplement Number: S208
• Date Received: 08/29/2018
• Decision Date: 09/27/2018
• Product Code: NJL
• Advisory Committee: Orthopedic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Change the inspection fixture and in-process inspection method of the ATTUNE Revision Tibial Augment components as part of the LCS Total Knee System.