| Device | OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM |
| Classification Name | Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing |
| Generic Name | Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-constrained, Metal/polymer, Mobile Bearing |
| Applicant | BIOMET MANUFACTURING CORP. |
| Date Received | 2005-11-01 |
| Decision Date | 2006-03-31 |
| PMA | P010014 |
| Supplement | S004 |
| Product Code | NRA |
| Advisory Committee | Orthopedic |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOMET MANUFACTURING CORP. 56 East Bell Drive p.o. Box 587 warsaw, IN 46581-0587 |
| Supplement Number | Date | Supplement Type |
|---|
| P010014 | | Original 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 |