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.
Approval for changes to the process specifications for the 9-stage kerry cleaning plant used in the ultrasonic cleaning of the oxford meniscal unicompartmental knee system metallic components (femoral and tibial). The changes require detailed monitoring of the ultrasonic equipment to ensure the adequacy of its output.
| Device | OXFORD MENISCAL UNICOMPARTMENTAL KNEE |
| 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 | 2006-07-03 |
| Decision Date | 2006-07-18 |
| PMA | P010014 |
| Supplement | S009 |
| Product Code | NRA |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| 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 |