| Device | NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM |
| Classification Name | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing |
| Generic Name | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing |
| Applicant | DEPUY, INC. |
| Date Received | 1986-06-10 |
| Decision Date | 1986-07-24 |
| PMA | P830055 |
| Supplement | S010 |
| Product Code | NJL |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEPUY, INC. p.o. Box 988 700 Orthopaedic Drive warsaw, IN 46581-0988 |
| Supplement Number | Date | Supplement Type |
|---|
| P830055 | | Original Filing |
| S303 |
2023-01-11 |
30-day Notice |
| S302 |
2023-01-05 |
30-day Notice |
| S301 | | |
| S300 |
2022-10-27 |
30-day Notice |
| S299 |
2022-09-30 |
30-day Notice |
| S298 | | |
| S297 |
2022-09-23 |
30-day Notice |
| S296 |
2022-09-07 |
30-day Notice |
| S295 |
2022-08-12 |
30-day Notice |
| S294 |
2022-08-01 |
30-day Notice |
| S293 |
2022-07-15 |
Special (immediate Track) |
| S292 |
2022-06-27 |
30-day Notice |
| S291 | | |
| S290 | | |
| S289 |
2022-06-01 |
Special (immediate Track) |
| S288 |
2022-04-19 |
30-day Notice |
| S287 | | |
| S286 | | |
| S285 |
2022-03-02 |
30-day Notice |
| S284 |
2022-02-22 |
Special (immediate Track) |
| S283 | | |
| S282 |
2022-02-11 |
30-day Notice |
| S281 |
2022-02-09 |
30-day Notice |
| S280 | | |
| S279 |
2022-01-12 |
30-day Notice |
| S278 |
2021-12-20 |
30-day Notice |
| S277 | | |
| S276 |
2021-11-09 |
Special (immediate Track) |
| S275 |
2021-09-27 |
30-day Notice |
| S274 |
2021-08-23 |
Special (immediate Track) |
| S273 | | |
| S272 | | |
| S271 |
2021-07-21 |
30-day Notice |
| S270 |
2021-07-07 |
Normal 180 Day Track No User Fee |
| S269 |
2021-06-16 |
Special (immediate Track) |
| S268 | | |
| S267 |
2021-06-09 |
30-day Notice |
| S266 |
2021-04-29 |
30-day Notice |
| S265 | | |
| S264 | | |
| S263 | | |
| S262 |
2021-02-10 |
30-day Notice |
| S261 |
2020-11-23 |
Normal 180 Day Track No User Fee |
| S260 |
2020-11-05 |
30-day Notice |
| S259 |
2020-10-28 |
30-day Notice |
| S258 |
2020-10-14 |
30-day Notice |
| S257 |
2020-09-22 |
Normal 180 Day Track No User Fee |
| S256 |
2020-09-21 |
30-day Notice |
| S255 |
2020-08-12 |
30-day Notice |
| S254 | | |
| S253 |
2020-07-15 |
30-day Notice |
| S252 | | |
| S251 |
2020-06-23 |
30-day Notice |
| S250 |
2020-06-18 |
30-day Notice |
| S249 | | |
| S248 |
2020-05-21 |
30-day Notice |
| S247 |
2020-05-18 |
30-day Notice |
| S246 |
2020-04-24 |
30-day Notice |
| S245 | | |
| S244 |
2020-04-14 |
Special (immediate Track) |
| S243 |
2020-03-30 |
30-day Notice |
| S242 |
2019-12-05 |
30-day Notice |
| S241 |
2019-11-27 |
30-day Notice |
| S240 |
2019-11-26 |
30-day Notice |
| S239 | | |
| S238 |
2019-11-05 |
Special (immediate Track) |
| S237 |
2019-10-15 |
30-day Notice |
| S236 |
2019-09-26 |
Real-time Process |
| S235 |
2019-08-23 |
Real-time Process |
| S234 |
2019-07-16 |
Special (immediate Track) |
| S233 |
2019-07-03 |
30-day Notice |
| S232 |
2019-05-16 |
Special (immediate Track) |
| S231 | | |
| S230 |
2019-04-18 |
30-day Notice |
| S229 |
2019-04-12 |
30-day Notice |
| S228 |
2019-04-09 |
30-day Notice |
| S227 |
2019-03-27 |
Special (immediate Track) |
| S226 |
2019-03-01 |
Normal 180 Day Track No User Fee |
| S225 |
2019-02-11 |
30-day Notice |
| S224 |
2019-02-05 |
30-day Notice |
| S223 |
2019-02-05 |
30-day Notice |
| S222 |
2019-02-04 |
30-day Notice |
| S221 |
2019-01-17 |
30-day Notice |
| S220 | | |
| S219 |
2018-11-15 |
30-day Notice |
| S218 |
2018-11-07 |
30-day Notice |
| S217 |
2018-11-02 |
Real-time Process |
| S216 |
2018-10-30 |
30-day Notice |
| S215 |
2018-10-25 |
Normal 180 Day Track No User Fee |
| S214 |
2018-10-16 |
30-day Notice |
| S213 |
2018-10-11 |
Real-time Process |
| S212 |
2018-09-27 |
30-day Notice |
| S211 |
2018-09-26 |
Normal 180 Day Track No User Fee |
| S210 |
2018-09-26 |
Normal 180 Day Track No User Fee |
| S209 |
2018-09-24 |
Special (immediate Track) |
| S208 |
2018-08-29 |
30-day Notice |
| S207 |
2018-08-27 |
30-day Notice |
| S206 |
2018-08-21 |
Special (immediate Track) |
| S205 |
2018-07-27 |
30-day Notice |
| S204 |
2018-06-04 |
30-day Notice |
| S203 |
2018-06-04 |
Real-time Process |
| S202 |
2018-05-31 |
Special (immediate Track) |
| S201 |
2018-05-01 |
30-day Notice |
| S200 |
2018-04-30 |
30-day Notice |
| S199 |
2018-04-06 |
30-day Notice |
| S198 |
2018-03-29 |
Real-time Process |
| S197 |
2018-03-22 |
Real-time Process |
| S196 |
2018-03-20 |
Real-time Process |
| S195 |
2018-02-05 |
Special (immediate Track) |
| S194 |
2018-02-02 |
30-day Notice |
| S193 |
2017-11-03 |
30-day Notice |
| S192 |
2017-09-28 |
Real-time Process |
| S191 |
2017-09-25 |
Special (immediate Track) |
| S190 |
2017-09-21 |
30-day Notice |
| S189 |
2017-09-20 |
30-day Notice |
| S188 |
2017-09-19 |
Real-time Process |
| S187 |
2017-08-30 |
30-day Notice |
| S186 |
2017-08-30 |
30-day Notice |
| S185 |
2017-06-27 |
Special (immediate Track) |
| S184 |
2017-06-21 |
Real-time Process |
| S183 |
2017-06-20 |
Real-time Process |
| S182 |
2017-05-10 |
30-day Notice |
| S181 |
2017-03-22 |
30-day Notice |
| S180 |
2017-01-27 |
30-day Notice |
| S179 |
2016-12-09 |
Normal 180 Day Track No User Fee |
| S178 |
2016-10-31 |
Special Supplement |
| S177 |
2016-10-26 |
30-day Notice |
| S176 |
2016-09-12 |
Real-time Process |
| S175 |
2016-08-22 |
30-day Notice |
| S174 |
2016-08-10 |
30-day Notice |
| S173 |
2016-07-19 |
Real-time Process |
| S172 |
2016-06-24 |
Real-time Process |
| S171 |
2016-06-13 |
30-day Notice |
| S170 |
2016-05-05 |
30-day Notice |
| S169 |
2016-03-18 |
30-day Notice |
| S168 |
2016-02-09 |
Real-time Process |
| S167 |
2016-01-27 |
30-day Notice |
| S166 |
2015-12-01 |
30-day Notice |
| S165 |
2015-11-25 |
30-day Notice |
| S164 |
2015-10-16 |
30-day Notice |
| S163 |
2015-06-16 |
30-day Notice |
| S162 |
2015-06-15 |
30-day Notice |
| S161 | | |
| S160 |
2015-06-03 |
30-day Notice |
| S159 |
2015-05-27 |
Special (immediate Track) |
| S158 |
2015-03-30 |
Special (immediate Track) |
| S157 |
2015-03-23 |
Real-time Process |
| S156 |
2015-03-20 |
30-day Notice |
| S155 |
2015-03-03 |
Special (immediate Track) |
| S154 |
2014-12-22 |
30-day Notice |
| S153 |
2014-11-24 |
30-day Notice |
| S152 |
2014-10-03 |
Real-time Process |
| S151 |
2014-09-10 |
30-day Notice |
| S150 |
2014-09-09 |
Normal 180 Day Track |
| S149 |
2014-09-08 |
30-day Notice |
| S148 | | |
| S147 |
2014-07-31 |
Special (immediate Track) |
| S146 |
2014-07-10 |
Special (immediate Track) |
| S145 |
2014-05-15 |
30-day Notice |
| S144 |
2014-04-30 |
Normal 180 Day Track No User Fee |
| S143 |
2014-04-16 |
Special (immediate Track) |
| S142 |
2014-03-19 |
Special (immediate Track) |
| S141 |
2014-01-27 |
Real-time Process |
| S140 |
2013-11-27 |
30-day Notice |
| S139 |
2013-09-26 |
Special (immediate Track) |
| S138 |
2013-09-23 |
135 Review Track For 30-day Notice |
| S137 |
2013-08-28 |
30-day Notice |
| S136 |
2013-07-29 |
Special (immediate Track) |
| S135 |
2013-06-13 |
30-day Notice |
| S134 |
2013-05-20 |
Normal 180 Day Track No User Fee |
| S133 |
2013-03-14 |
Special (immediate Track) |
| S132 |
2013-03-12 |
135 Review Track For 30-day Notice |
| S131 |
2013-02-27 |
30-day Notice |
| S130 |
2013-02-14 |
30-day Notice |
| S129 |
2012-11-13 |
Normal 180 Day Track No User Fee |
| S128 |
2012-10-17 |
Special (immediate Track) |
| S127 |
2012-08-16 |
Real-time Process |
| S126 |
2012-01-31 |
Real-time Process |
| S125 |
2012-01-23 |
Special (immediate Track) |
| S124 |
2012-01-17 |
Real-time Process |
| S123 | | |
| S122 |
2011-12-08 |
Real-time Process |
| S121 |
2011-07-18 |
Real-time Process |
| S120 | | |
| S119 |
2011-02-18 |
135 Review Track For 30-day Notice |
| S118 |
2011-02-18 |
135 Review Track For 30-day Notice |
| S117 |
2010-12-23 |
Special (immediate Track) |
| S116 |
2010-11-15 |
Normal 180 Day Track No User Fee |
| S115 |
2010-11-01 |
135 Review Track For 30-day Notice |
| S114 |
2009-12-10 |
Special (immediate Track) |
| S113 |
2009-11-27 |
30-day Notice |
| S112 |
2009-10-06 |
Special (immediate Track) |
| S111 |
2009-06-10 |
Real-time Process |
| S110 |
2009-04-06 |
30-day Notice |
| S109 |
2009-02-17 |
Real-time Process |
| S108 |
2009-01-28 |
135 Review Track For 30-day Notice |
| S107 |
2008-12-22 |
Normal 180 Day Track |
| S106 |
2008-09-30 |
Normal 180 Day Track |
| S105 | | |
| S104 |
2008-08-07 |
Real-time Process |
| S103 |
2008-06-13 |
Special (immediate Track) |
| S102 | | |
| S101 |
2008-01-14 |
Real-time Process |
| S100 | | |
| S099 |
2007-07-16 |
Real-time Process |
| S098 |
2006-08-21 |
135 Review Track For 30-day Notice |
| S097 |
2006-05-15 |
135 Review Track For 30-day Notice |
| S096 |
2006-02-21 |
Special (immediate Track) |
| S095 |
2006-02-09 |
Special (immediate Track) |
| S094 |
2005-12-19 |
Special (immediate Track) |
| S093 |
2005-11-10 |
Special (immediate Track) |
| S092 |
2005-10-27 |
Special (immediate Track) |
| S091 |
2005-08-29 |
Special (immediate Track) |
| S090 |
2005-07-18 |
Real-time Process |
| S089 |
2004-09-13 |
Real-time Process |
| S088 |
2004-01-26 |
Real-time Process |
| S087 |
2003-09-16 |
Real-time Process |
| S086 |
2003-07-07 |
Real-time Process |
| S085 |
2003-06-06 |
Normal 180 Day Track No User Fee |
| S084 |
2003-04-22 |
Real-time Process |
| S083 |
2002-11-05 |
Real-time Process |
| S082 |
2002-03-28 |
Normal 180 Day Track |
| S081 |
2001-11-06 |
Real-time Process |
| S080 |
2001-06-29 |
Normal 180 Day Track |
| S079 |
2001-06-20 |
Real-time Process |
| S078 |
2001-05-15 |
Real-time Process |
| S077 |
2000-09-26 |
Real-time Process |
| S076 |
2000-10-05 |
Real-time Process |
| S075 |
2000-08-17 |
Normal 180 Day Track |
| S074 |
2000-05-15 |
Real-time Process |
| S073 |
2000-04-21 |
Real-time Process |
| S072 |
2000-03-30 |
Real-time Process |
| S071 | | |
| S070 |
2000-02-17 |
Normal 180 Day Track |
| S069 |
2000-02-14 |
Real-time Process |
| S068 |
2000-02-03 |
Normal 180 Day Track |
| S067 |
1999-10-18 |
Real-time Process |
| S066 |
1999-09-20 |
Real-time Process |
| S065 |
1999-09-02 |
Real-time Process |
| S064 |
1999-08-30 |
Real-time Process |
| S063 |
1999-07-09 |
Real-time Process |
| S062 |
1999-06-21 |
Real-time Process |
| S061 |
1999-05-11 |
Real-time Process |
| S060 |
1998-09-11 |
Normal 180 Day Track |
| S059 |
1998-04-27 |
Real-time Process |
| S058 |
1998-04-09 |
Normal 180 Day Track |
| S057 |
1998-03-24 |
Real-time Process |
| S056 |
1997-11-25 |
Real-time Process |
| S055 |
1997-05-09 |
Real-time Process |
| S054 |
1997-04-07 |
Real-time Process |
| S053 |
1997-03-28 |
Normal 180 Day Track |
| S052 | | |
| S051 |
1996-09-25 |
Real-time Process |
| S050 |
1996-09-12 |
Real-time Process |
| S049 |
1996-09-10 |
Real-time Process |
| S048 |
1996-09-10 |
Real-time Process |
| S047 |
1996-03-21 |
Real-time Process |
| S046 |
1995-11-30 |
Normal 180 Day Track |
| S045 | | |
| S044 |
1995-06-15 |
Normal 180 Day Track |
| S043 |
1995-05-23 |
Normal 180 Day Track |
| S042 |
1995-04-14 |
Normal 180 Day Track |
| S041 |
1995-03-13 |
Normal 180 Day Track |
| S040 |
1995-02-24 |
Normal 180 Day Track |
| S039 | | |
| S038 |
1994-08-16 |
Normal 180 Day Track |
| S037 | | |
| S036 |
1994-06-30 |
Normal 180 Day Track |
| S035 |
1994-06-22 |
Normal 180 Day Track |
| S034 |
1994-03-14 |
Normal 180 Day Track |
| S033 |
1994-01-21 |
Normal 180 Day Track |
| S032 |
1993-11-10 |
Normal 180 Day Track |
| S031 |
1993-09-15 |
Normal 180 Day Track |
| S030 |
1993-07-19 |
Normal 180 Day Track |
| S029 |
1993-01-08 |
Normal 180 Day Track |
| S028 |
1992-12-18 |
Normal 180 Day Track |
| S027 |
1992-12-16 |
Normal 180 Day Track |
| S026 | | |
| S025 |
1992-11-23 |
Normal 180 Day Track |
| S024 |
1992-11-23 |
Normal 180 Day Track |
| S023 |
1992-11-02 |
Normal 180 Day Track |
| S022 |
1992-07-24 |
Normal 180 Day Track |
| S021 |
1992-03-09 |
Normal 180 Day Track |
| S020 | | |
| S019 |
1991-07-08 |
Normal 180 Day Track |
| S018 |
1991-04-29 |
Normal 180 Day Track |
| S017 |
1991-04-26 |
Panel Track |
| S016 |
1991-01-16 |
Normal 180 Day Track |
| S015 |
1989-12-18 |
Normal 180 Day Track |
| S014 |
1989-10-16 |
Panel Track |
| S013 |
1988-11-21 |
Normal 180 Day Track |
| S012 |
1988-04-13 |
Normal 180 Day Track |
| S011 | | |
| S010 |
1986-06-10 |
Special (immediate Track) |
| S009 |
1986-05-21 |
|
| S008 |
1986-03-25 |
|
| S007 |
1986-01-22 |
|
| S006 |
1985-11-18 |
|
| S005 |
1985-06-11 |
|
| S004 | | |
| S003 |
1985-04-17 |
|
| S002 |
1985-03-11 |
Normal 180 Day Track |
| S001 |
1984-12-18 |
Normal 180 Day Track |