Oxford Partial Knee System

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing

FDA Premarket Approval P010014 S096

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.

Pre-market Approval Supplement Details

Firm updated their vei label verification system.

DeviceOxford Partial Knee System
Classification NameProsthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing
Generic NameProsthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing
ApplicantBIOMET MANUFACTURING CORP.
Date Received2019-10-09
Decision Date2019-11-05
PMAP010014
SupplementS096
Product CodeNRA
Advisory CommitteeOrthopedic
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address BIOMET MANUFACTURING CORP. 56 East Bell Drive p.o. Box 587 warsaw, IN 46581-0587

Supplemental Filings

Supplement NumberDateSupplement Type
P010014Original Filing
S096 2019-10-09 Special (immediate Track)
S095
S094 2019-09-11 30-day Notice
S093 2019-08-29 30-day Notice
S092 2019-08-19 30-day Notice
S091 2019-08-12 30-day Notice
S090 2019-07-11 30-day Notice
S089 2019-04-26 Real-time Process
S088 2019-04-15 30-day Notice
S087 2019-04-15 Special (immediate Track)
S086 2019-04-03 30-day Notice
S085 2019-03-18 30-day Notice
S084 2019-01-17 Real-time Process
S083 2018-11-20 30-day Notice
S082 2018-09-25 30-day Notice
S081 2018-07-03 135 Review Track For 30-day Notice
S080 2018-06-28 30-day Notice
S079 2018-06-19 30-day Notice
S078
S077 2018-04-27 30-day Notice
S076 2018-04-27 135 Review Track For 30-day Notice
S075 2018-04-04 30-day Notice
S074 2018-03-22 Special (immediate Track)
S073 2018-03-20 30-day Notice
S072 2018-03-14 30-day Notice
S071 2018-03-05 Real-time Process
S070 2018-02-15 Special (immediate Track)
S069 2018-01-24 30-day Notice
S068 2017-11-16 Special (immediate Track)
S067 2017-09-11 30-day Notice
S066 2017-09-06 30-day Notice
S065 2017-08-15 Special (immediate Track)
S064
S063 2017-06-09 Special (immediate Track)
S062 2017-05-05 30-day Notice
S061 2017-02-17 30-day Notice
S060 2017-01-30 30-day Notice
S059 2016-10-18 Special (immediate Track)
S058 2016-10-11 Special (immediate Track)
S057 2016-09-22 30-day Notice
S056 2016-09-21 Special (immediate Track)
S055 2016-08-05 Special (immediate Track)
S054 2016-03-28 30-day Notice
S053 2015-10-07 30-day Notice
S052 2015-10-02 Special (immediate Track)
S051 2015-04-06 Special (immediate Track)
S050 2015-01-20 30-day Notice
S049 2014-10-14 30-day Notice
S048 2014-05-30 Special (immediate Track)
S047 2013-11-18 30-day Notice
S046 2013-09-20 30-day Notice
S045 2013-07-22 Special (immediate Track)
S044 2013-07-12 Special (immediate Track)
S043 2013-04-22 Normal 180 Day Track No User Fee
S042 2013-03-27 Special (immediate Track)
S041 2013-01-03 Normal 180 Day Track No User Fee
S040 2012-11-23 30-day Notice
S039 2012-11-05 135 Review Track For 30-day Notice
S038
S037 2012-07-16 30-day Notice
S036 2012-07-02 Special (immediate Track)
S035 2012-06-25 Special (immediate Track)
S034
S033 2012-01-05 Special (immediate Track)
S032 2011-06-29 30-day Notice
S031 2011-05-31 Real-time Process
S030 2011-02-22 30-day Notice
S029 2010-10-26 135 Review Track For 30-day Notice
S028 2010-11-09 Real-time Process
S027 2010-07-02 Normal 180 Day Track No User Fee
S026 2009-12-29 Real-time Process
S025
S024 2009-09-10 135 Review Track For 30-day Notice
S023
S022 2008-10-24 Special (immediate Track)
S021 2008-06-18 Real-time Process
S020 2008-06-11 135 Review Track For 30-day Notice
S019
S018 2007-11-20 135 Review Track For 30-day Notice
S017
S016 2007-08-10 Special (immediate Track)
S015 2007-02-27 135 Review Track For 30-day Notice
S014 2006-12-26 Normal 180 Day Track No User Fee
S013
S012 2006-11-16 135 Review Track For 30-day Notice
S011 2006-11-15 30-day Notice
S010
S009 2006-07-03 Special (immediate Track)
S008 2006-02-09 Real-time Process
S007
S006 2005-11-02 135 Review Track For 30-day Notice
S005 2005-11-01 Normal 180 Day Track No User Fee
S004 2005-11-01 135 Review Track For 30-day Notice
S003 2005-10-28 135 Review Track For 30-day Notice
S002 2005-04-26 Real-time Process
S001 2004-06-04 Normal 180 Day Track No User Fee

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