LCS(R) Total Knee System

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing

FDA Premarket Approval P830055 S235

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 the use of components of the attune revision knee system with compatible components of the attune primary cemented and cementless devices.

DeviceLCS(R) Total Knee System
Classification NameProsthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
Generic NameProsthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
ApplicantDEPUY, INC.
Date Received2019-08-23
Decision Date2019-11-21
PMAP830055
SupplementS235
Product CodeNJL
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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
S237 2019-10-15 30-day Notice
S236
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
10603295007999 P830055 000
10603295007975 P830055 000
10603295007982 P830055 000
10603295008019 P830055 000
10603295008002 P830055 000
10603295008057 P830055 001
10603295008040 P830055 001
10603295008033 P830055 001
10603295008026 P830055 001
10603295007920 P830055 001
10603295007968 P830055 001
10603295007951 P830055 001
10603295007944 P830055 001
10603295007937 P830055 001
10603295008064 P830055 001
10603295020578 P830055 007
10603295020585 P830055 007
10603295020707 P830055 007
10603295020684 P830055 007
10603295020660 P830055 007
10603295020646 P830055 007
10603295020622 P830055 007
10603295020615 P830055 007
10603295020608 P830055 007
10603295020592 P830055 007
10603295026242 P830055 078
10603295026235 P830055 078
10603295026228 P830055 078
10603295026211 P830055 078
10603295026204 P830055 078
10603295232803 P830055 099

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