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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceLCS(R) TOTAL KNEE SYSTEM
Generic NameProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing
ApplicantDEPUY, INC.
P.O. BOX 988
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988
PMA NumberP830055
Date Received08/16/1983
Decision Date04/12/1985
Product Code NJL 
Docket Number 85M-0195
Notice Date 05/20/1985
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements:  S001 S002 S003 S005 S006 S007 S008 S009 S010 S012 S013 
S014 S015 S016 S017 S018 S019 S021 S022 S023 S024 S025 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 S038 S040 S041 
S042 S043 S044 S046 S047 S048 S049 S050 S051 S053 S054 S055 
S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 S066 S067 
S068 S069 S070 S072 S073 S074 S075 S076 S077 S078 S079 S080 
S081 S082 S083 S084 S085 S086 S087 S088 S089 S090 S091 S092 
S093 S094 S095 S096 S097 S098 S099 S101 S103 S104 S106 S107 
S108 S109 S110 S111 S112 S113 S114 S115 S116 S117 S118 S119 
S121 S122 S124 S125 S126 S127 S128 S129 S130 S131 S132 S133 
S134 S135 S136 S137 S138 S139 S140 S141 S142 S143 S144 S145 
S146 S147 S149 S150 S151 S152 S153 S154 S155 S156 S157 S158 
S159 S160 S162 S163 S164 S165 S166 S167 S168 S169 S170 S171 
S172 S173 S174 S175 S176 S177 S178 S179 S180 S181 S182 S183 
S184 S185 S186 S187 S188 S189 S190 S191 S192 S193 S194 S195 
S196 S197 S198 S199 S200 S201 S202 S203 S204 S205 S206 S207 
S208 S209 S210 S211 S212 S213 S214 S215 S216 S217 S218 S219 
S220 S221 S222 S223 S224 S225 S226 S227 S228 S229 S230 S231 
S232 S233 S234 S235 S236 S237 S238 S239 S240 S241 S242 S243 
S244 S245 S246 S247 S248 S249 S250 S251 S252 S253 S254 S255 
S256 S257 S258 S259 S260 S261 S262 S263 S264 S265 S266 S267 
S268 S269 S270 S271 S272 S273 S274 S275 S276 S277 S278 S279 
S280 S281 S282 S284 S285 S286 S287 S288 S289 S292 S293 S294 
S295 S296 S297 S298 S299 S300 S301 S302 S303 S304 S305 S307 
S308 S309 S310 S311 S312 S313 S314 S315 S316 S317 S318 S319 
S322 S323 S324 S326 S327 S328 S329 S330 S331 S332 S333 S335 
S336 S337 
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