LCS Total Knee System

FDA Premarket Approval P830055 S257

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.

Pre-market Approval Supplement Details

Approval for a manufacturing site located at johnson & johnson medical (depuy suzhou) ltd. , no. 299, changyang street, suzhou industrial park, suzhou jiangsu, china, to manufacture sigma ps femur components of the lcs total knee system.

DeviceLCS Total Knee System
Generic NameProsthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
ApplicantDEPUY, INC.
Date Received2020-09-22
Decision Date2020-10-21
PMAP830055
SupplementS257
Product CodeNJL 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DEPUY, INC. p.o. Box 988 700 Orthopaedic Drive warsaw, IN 46581-0988

Supplemental Filings

Supplement NumberDateSupplement Type
P830055Original Filing
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

NIH GUDID Devices

Device IDPMASupp
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