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.
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.
| Device | OXFORD(TM) 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 | 2001-03-01 |
| Decision Date | 2004-04-21 |
| Notice Date | 2004-05-05 |
| PMA | P010014 |
| Supplement | S |
| Product Code | NRA |
| Docket Number | 04M-0200 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOMET MANUFACTURING CORP. 56 East Bell Drive p.o. Box 587 warsaw, IN 46581-0587 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |