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 nexgen fluted stem mobile tibial component,resulting in the nexgen minimally invasive solutions (mis) lps-mobile tibial component. Changes made to the nexgen fluted stem mobile tibial component include shortening thetibial baseplate stem and adding broad proximal fins, changing the outer profile radius of thebaseplate edge from a variable radius to a constant radius, and adding an additional size (4-plus)to the current range of sizes (1 - 8).
| Device | NEXGEN COMPLETE KNEE SOLUTION |
| 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 | 2008-09-29 |
| Decision Date | 2009-03-26 |
| PMA | P060037 |
| Supplement | S005 |
| Product Code | NJL |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |