FDA.reportPublic FDA data

PMA P910016S012

Device
LCS UNI TOTAL KNEE SYSTEM
Applicant
Depuy, Inc.
PMA number
P910016
Supplement
S012
Product code
MBD
Decision date
2002-02-04
Classification
Orthopedic
Generic name
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
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.

Current openFDA PMA Record#

Device
LCS UNI TOTAL KNEE SYSTEM
Applicant
Depuy, Inc.
PMA number
P910016
Supplement
S012
Product code
MBD
Generic name
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Decision date
2002-02-04
Decision code
APPR
Date received
2001-12-12
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
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.