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 DRIVE; WARSAW, IN 46581-0988
• PMA Number: P830055
• Supplement Number: S307
• Date Received: 05/09/2023
• Decision Date: 05/19/2023
• 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

Approval Order Statement  
Removal of the duplicate inspections from different steps of the manufacturing process for the LCS Total Knee System.