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 addition of inspection checks at the case creation stage and the segmentation stage, for the trumatch personalized solutions patient-specific instruments for total knee arthroplasty, within the lcs total knee system
| Device | LCS Total Knee System |
| Generic Name | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing |
| Applicant | DEPUY, INC. |
| Date Received | 2021-08-23 |
| Decision Date | 2021-09-10 |
| PMA | P830055 |
| Supplement | S274 |
| Product Code | NJL |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| 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 |