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 ¿ P.F.C. SIGMA RPF FEMORAL COMPONENTS
• 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: S112
• Date Received: 10/06/2009
• Decision Date: 12/08/2009
• Product Code: NJL
• Advisory Committee: Orthopedic
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR ADDITIONAL IN-PROCESS DIMENSIONAL INSPECTIONS OF THE P.F.C. SIGMA RPF FEMORAL COMPONENTS.