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.
To establish the safc st. Louis site as an additional supplier of aox antioxidant solution to ensure continued availability of the aox bar stock material, which is used in manufacture of the attune revision crs rotating platform inserts, the attune cr rotating platform inserts, the attune ps rotating platform inserts, thesigma rotating platform ao curved tibial inserts, and the sigma rotating platform ao stabilized tibial inserts at the depuy cork site; and of the lcs complete rps aox inserts, the lcs complete rp aox inserts and the sigma rpf aox inserts at the depuy raynham site.
| Device | LCS Total Knee System |
| Generic Name | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing |
| Applicant | DEPUY, INC. |
| Date Received | 2020-10-28 |
| Decision Date | 2020-11-27 |
| PMA | P830055 |
| Supplement | S259 |
| 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 | 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 |