OXFORD PARTIAL KNEE SYSTEM

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

FDA Premarket Approval P010014 S052

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

Approval for an update to its process engineering specification that controls the sealing parameters for the sterile packaging for the oxford partial knee 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 Received2015-10-02
Decision Date2015-10-30
PMAP010014
SupplementS052
Product CodeNRA
Advisory CommitteeOrthopedic
Supplement TypeSpecial (immediate Track)
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
S103 2022-09-29 30-day Notice
S102 2022-06-14 Special (immediate Track)
S101 2022-03-11 30-day Notice
S100 2020-10-16 Normal 180 Day Track No User Fee
S099
S098
S097 2019-12-03 135 Review Track For 30-day Notice
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 2007-08-22 Real-time Process
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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