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: NEW JERSEY LCS(R) 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: S023
• Date Received: 11/02/1992
• Decision Date: 07/22/1993
• Product Code: NJL
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls