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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
Generic NameProsthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
ApplicantBIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
P.O. BOX 587
WARSAW, IN 46581-0587
PMA NumberP010014
Date Received03/01/2001
Decision Date04/21/2004
Product Code NRA 
Docket Number 04M-0200
Notice Date 05/05/2004
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (PHASE 3). THE DEVICE IS INDICATED FOR USE IN PATIENTS WITH OSTEOARTHRITIS OR AVASCULAR NECROSIS LIMITED TO THE MEDIAL COMPARTMENT OF THE KNEE AND INTENDED TO BE IMPLANTED WITH BONE CEMENT.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S008 S011 S012 S029 S027 S028 S002 S016 S017 S018 S001 S014 
S015 S020 S021 S022 S071 S072 S073 S074 S075 S101 S066 S067 
S062 S063 S054 S060 S061 S058 S059 S055 S026 S024 S030 S031 
S032 S033 S035 S036 S037 S048 S049 S050 S051 S052 S053  
S103 S039 S040 S041 S042 S043 S044 S045 S046 S047 S003 S004 
S005 S006 S009 S056 S057 S087 S088 S089 S094 S096 S084 S104 
S108 S065 S069 S076 S077 S068 S082 S079 S080 S081 S070 S090 
S091 S092 S093 S083 S097 S098 S085 S086 S102 S100 S107 S106 
S105 
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