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: UNICOMPARTMENTAL DEVICE CONFIGURATION OF THE LCS TOTAL KNEE SYSTEM
• Generic Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
• Applicant: Depuy, Inc.; 700 Orthopaedic Dr.; Warsaw, IN 46581
• PMA Number: P910016
• Supplement Number: S014
• Date Received: 05/23/2005
• Decision Date: 09/26/2005
• Withdrawal Date: 04/18/2012
• Product Code: MBD
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR CHANGES TO THE POST-APPROVAL STUDY.