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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameOXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
Classification Nameprosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing
Generic Nameknee, unicompartmental, metal/polymer, cemented, mobile bearing
ApplicantBIOMET MANUFACTURING CORP.
PMA NumberP010014
Date Received03/01/2001
Decision Date04/21/2004
Product Code
NRA[ Registered Establishments with NRA ]
Docket Number 04M-0200
Notice Date 05/05/2004
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH 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 Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S011 
S012 S014 S015 S016 S017 S018 S020 S021 S022 
S024 S026 S027 S028 S029 S030 S031 S032 S033 
S035 S036 S037 S039 S040 S041 S042 S043 S044 
S045 S046 S047 S048 
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