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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceLCS UNI TOTAL KNEE SYSTEM
Generic NamePROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
ApplicantDEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW, IN 46581-0988
PMA NumberP910016
Supplement NumberS012
Date Received12/12/2001
Decision Date02/04/2002
Withdrawal Date 04/18/2012
Product Code MBD 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MINOR DESIGN MODIFICATIONS TO THE TIBIAL TRAY AND TIBIAL BEARING COMPONENTS OF THE LCS UNI TOTAL KNEE SYSTEM. THESE MODIFICATIONS INCLUDE: A CHANGE TO THE PROXIMAL ARTICULATING SURFACE OF THE TIBIAL BEARING IN ORDER TO ACCOMMODATE IT'S USE WITH THE PRESERVATION UNI FEMORAL COMPONENT; A CHANGE IN POLYETHYLENE RAW MATERIAL; A 1 MM REDUCTION IN THE DOVETAIL HEIGHT OF THE POLYETHYLENE BEARING; REFINING THE OUTER PROFILE OF THE TIBIAL TRAY TO BE LEFT/RIGHT SPECIFIC AND TO OPTIMIZE THE TIBIAL BONE COVERAGE; CEMENTED USE ONLY; REPLACING THE POROUS COATING ON THE TIBIAL TRAY WITH A GRIT-BLAST SURFACE FINISH; AND, REPLACING THE FIXATION PEG WITH A FIXATION KEEL. THE DEVICE COMPONENTS, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRESERVATION UNI MOBILE BEARING KNEE SYSTEM, AND ARE INDICATED FOR CEMENTED USE IN PATIENTS OVER 60 YEARS OLD UNDERGOING UNICOMPARTMENTAL KNEE SURGERY FOR REHABILITATING KNEES WHEN ONLY ONE CONDYLE HAS BEEN DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS OR POST-TRAUMATIC ARTHRITIS.
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