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.
Removal of the cytotoxicity test requirement from the routine process monitoring of the final cleaning process for the nexgen®complete knee solution, legacy® knee – posterior stabilized (lps) and the lps-flex mobile bearing knee femoral components, at the shannon, ireland facility
| Device | Nexgen LPS-Flex/LPS-Mobile Bearing Knee |
| Classification Name | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing |
| Generic Name | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing |
| Applicant | ZIMMER, INC. |
| Date Received | 2019-07-11 |
| Decision Date | 2019-08-07 |
| PMA | P060037 |
| Supplement | S061 |
| Product Code | NJL |
| Advisory Committee | Orthopedic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ZIMMER, INC. p.o. Box 708 warsaw, IN 46581-0708 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060037 | Original Filing | |
| S082 | 2022-09-30 | 30-day Notice |
| S081 | ||
| S080 | 2022-07-25 | Special (immediate Track) |
| S079 | 2022-05-09 | 30-day Notice |
| S078 | 2022-03-07 | 30-day Notice |
| S077 | 2022-01-31 | 30-day Notice |
| S076 | 2021-12-10 | 30-day Notice |
| S075 | 2021-09-30 | 30-day Notice |
| S074 | 2021-08-10 | 30-day Notice |
| S073 | ||
| S072 | 2021-06-21 | 30-day Notice |
| S071 | 2021-06-10 | 30-day Notice |
| S070 | 2020-11-25 | 30-day Notice |
| S069 | 2020-09-28 | Real-time Process |
| S068 | 2020-09-21 | 30-day Notice |
| S067 | 2020-09-17 | 30-day Notice |
| S066 | 2020-07-28 | 30-day Notice |
| S065 | 2020-06-16 | 30-day Notice |
| S064 | 2020-05-07 | 30-day Notice |
| S063 | ||
| S062 | 2019-09-26 | 30-day Notice |
| S061 | 2019-07-11 | 30-day Notice |
| S060 | 2019-06-03 | 30-day Notice |
| S059 | ||
| S058 | ||
| S057 | 2018-11-07 | 30-day Notice |
| S056 | 2018-04-23 | 30-day Notice |
| S055 | 2018-02-27 | 30-day Notice |
| S054 | 2018-02-20 | 30-day Notice |
| S053 | 2017-10-19 | 30-day Notice |
| S052 | 2017-09-29 | 30-day Notice |
| S051 | 2017-09-07 | 30-day Notice |
| S050 | 2017-08-31 | 30-day Notice |
| S049 | 2017-06-07 | 30-day Notice |
| S048 | 2016-11-23 | 30-day Notice |
| S047 | 2016-09-08 | Normal 180 Day Track No User Fee |
| S046 | 2016-08-08 | 30-day Notice |
| S045 | 2016-05-03 | 30-day Notice |
| S044 | 2016-03-31 | 30-day Notice |
| S043 | 2015-12-17 | Special (immediate Track) |
| S042 | 2015-10-30 | 30-day Notice |
| S041 | 2015-10-16 | 30-day Notice |
| S040 | 2015-09-30 | 30-day Notice |
| S039 | 2015-08-12 | 30-day Notice |
| S038 | 2015-06-29 | 135 Review Track For 30-day Notice |
| S037 | 2015-06-26 | 30-day Notice |
| S036 | 2015-06-22 | Special (immediate Track) |
| S035 | 2015-03-17 | 30-day Notice |
| S034 | 2015-02-24 | 30-day Notice |
| S033 | 2014-12-04 | 30-day Notice |
| S032 | 2014-09-30 | 135 Review Track For 30-day Notice |
| S031 | 2014-08-28 | 135 Review Track For 30-day Notice |
| S030 | 2014-02-18 | Normal 180 Day Track No User Fee |
| S029 | 2014-01-22 | 30-day Notice |
| S028 | 2013-09-30 | 135 Review Track For 30-day Notice |
| S027 | 2013-09-23 | 135 Review Track For 30-day Notice |
| S026 | 2013-08-08 | Normal 180 Day Track No User Fee |
| S025 | ||
| S024 | 2013-07-15 | 135 Review Track For 30-day Notice |
| S023 | 2013-07-01 | 30-day Notice |
| S022 | 2013-05-23 | 30-day Notice |
| S021 | 2013-03-25 | 135 Review Track For 30-day Notice |
| S020 | 2012-09-27 | 135 Review Track For 30-day Notice |
| S019 | 2012-08-21 | 135 Review Track For 30-day Notice |
| S018 | 2012-07-13 | 30-day Notice |
| S017 | 2012-04-06 | 135 Review Track For 30-day Notice |
| S016 | 2012-01-12 | 30-day Notice |
| S015 | 2011-11-23 | 30-day Notice |
| S014 | 2011-07-05 | 135 Review Track For 30-day Notice |
| S013 | 2010-05-12 | Special (immediate Track) |
| S012 | 2010-04-06 | Normal 180 Day Track No User Fee |
| S011 | 2009-06-10 | 30-day Notice |
| S010 | 2009-05-22 | Special (immediate Track) |
| S009 | 2009-04-24 | Normal 180 Day Track |
| S008 | 2009-04-21 | 30-day Notice |
| S007 | 2008-11-25 | Real-time Process |
| S006 | 2008-10-10 | 135 Review Track For 30-day Notice |
| S005 | 2008-09-29 | Normal 180 Day Track |
| S004 | 2008-09-02 | Normal 180 Day Track No User Fee |
| S003 | 2008-06-06 | 135 Review Track For 30-day Notice |
| S002 | ||
| S001 | 2008-01-29 | 30-day Notice |