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 updates to the package insert which included the following: strengthening and clarification of the importance of following the surgical technique, additional wording to clarify a precaution to the end user, expanded language for a possible adverse event about foreign material sensitivity and reformatting of the magnetic resonance (mr) section.
| Device | OXFORD PATIAL 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 | 2012-07-02 |
| Decision Date | 2012-08-02 |
| PMA | P010014 |
| Supplement | S036 |
| Product Code | NRA |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |