LCS(R) TOTAL KNEE SYSTEM

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

FDA Premarket Approval P830055

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.

Pre-market Approval Supplement Details

• Device: LCS(R) TOTAL KNEE SYSTEM
• Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
• Generic Name: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Metal/polymer, Mobile Bearing
• Applicant: DEPUY, INC.
• Date Received: 1983-08-16
• Decision Date: 1985-04-12
• Notice Date: 1985-05-20
• PMA: P830055
• Supplement: S
• Product Code: NJL
• Docket Number: 85M-0195
• Advisory Committee: Orthopedic
• Expedited Review: No
• Combination Product: No
• Applicant Address: DEPUY, INC. p.o. Box 988 700 Orthopaedic Drive warsaw, IN 46581-0988

Supplemental Filings

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

NIH GUDID Devices

Device ID	PMA	Supp
10603295008002	P830055	000
10603295008019	P830055	000
10603295007999	P830055	000
10603295007982	P830055	000
10603295007975	P830055	000
10603295007968	P830055	001
10603295007951	P830055	001
10603295007937	P830055	001
10603295007920	P830055	001
10603295008026	P830055	001
10603295008033	P830055	001
10603295008040	P830055	001
10603295008057	P830055	001
10603295008064	P830055	001
10603295007944	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
10603295021254	P830055	022
10603295021247	P830055	022
10603295021230	P830055	022
10603295021223	P830055	022
10603295021216	P830055	022
10603295021209	P830055	022
10603295021261	P830055	022
10603295021278	P830055	022
10603295020264	P830055	022
10603295020240	P830055	022
10603295020257	P830055	022
10603295020233	P830055	022
10603295020219	P830055	022
10603295021285	P830055	022
10603295020288	P830055	022
10603295020226	P830055	022
10603295020271	P830055	022
10603295040293	P830055	043
10603295040200	P830055	043
10603295040187	P830055	043
10603295040170	P830055	043
10603295040132	P830055	043
10603295021650	P830055	073
10603295021643	P830055	073
10603295021636	P830055	073
10603295021629	P830055	073
10603295021605	P830055	073
10603295021520	P830055	073
10603295021537	P830055	073
10603295021551	P830055	073
10603295021568	P830055	073
10603295021575	P830055	073
10603295021582	P830055	073
10603295021599	P830055	073
10603295025986	P830055	074
10603295025979	P830055	074
10603295025993	P830055	074
10603295025962	P830055	074
10603295025603	P830055	074
10603295025610	P830055	074
10603295025627	P830055	074
10603295025634	P830055	074
10603295025641	P830055	074
10603295025757	P830055	074
10603295025764	P830055	074
10603295025771	P830055	074
10603295025788	P830055	074
10603295025795	P830055	074
10603295025818	P830055	074
10603295025825	P830055	074
10603295025924	P830055	074
10603295025931	P830055	074
10603295025948	P830055	074
10603295025566	P830055	074
10603295025597	P830055	074
10603295025733	P830055	074
10603295025894	P830055	074
10603295025887	P830055	074
10603295025863	P830055	074
10603295025849	P830055	074
10603295025832	P830055	074
10603295025955	P830055	074
10603295025665	P830055	074
10603295025672	P830055	074
10603295025689	P830055	074
10603295025696	P830055	074
10603295025702	P830055	074
10603295025719	P830055	074
10603295025726	P830055	074
10603295025900	P830055	074
10603295025917	P830055	074
10603295025580	P830055	074
10603295025658	P830055	074
10603295025870	P830055	074
10603295025573	P830055	074
10603295025801	P830055	074
10603295025740	P830055	074
10603295026228	P830055	078
10603295026211	P830055	078
10603295026242	P830055	078
10603295026204	P830055	078
10603295026235	P830055	078
10603295021612	P830055	079
10603295021544	P830055	079
10603295026099	P830055	086
10603295026112	P830055	086
10603295026150	P830055	086
10603295026068	P830055	086
10603295026075	P830055	086
10603295026181	P830055	086
10603295026174	P830055	086
10603295026167	P830055	086
10603295026143	P830055	086
10603295026129	P830055	086
10603295026136	P830055	086
10603295026082	P830055	086
10603295026105	P830055	086
10603295026198	P830055	086
10603295224006	P830055	087
10603295224082	P830055	087
10603295224099	P830055	087
10603295224068	P830055	087
10603295224075	P830055	087
10603295224105	P830055	087
10603295224112	P830055	087
10603295224129	P830055	087
10603295224044	P830055	087
10603295224037	P830055	087
10603295224136	P830055	087
10603295223993	P830055	087
10603295223986	P830055	087
10603295224051	P830055	087
10603295224013	P830055	087
10603295224020	P830055	087
10603295026006	P830055	089
10603295026051	P830055	089
10603295026044	P830055	089
10603295026037	P830055	089
10603295026020	P830055	089
10603295026013	P830055	089
10603295022855	P830055	090
10603295025450	P830055	090
10603295022831	P830055	090
10603295025498	P830055	090
10603295022824	P830055	090
10603295025436	P830055	090
10603295025443	P830055	090
10603295025467	P830055	090
10603295025474	P830055	090
10603295025481	P830055	090
10603295025504	P830055	090
10603295025511	P830055	090
10603295025528	P830055	090
10603295025535	P830055	090
10603295025542	P830055	090
10603295025559	P830055	090
10603295022947	P830055	090
10603295025429	P830055	090
10603295022923	P830055	090
10603295022930	P830055	090
10603295022909	P830055	090
10603295022954	P830055	090
10603295022893	P830055	090
10603295022886	P830055	090
10603295022879	P830055	090
10603295022862	P830055	090
10603295022848	P830055	090
10603295022916	P830055	090
10603295022435	P830055	093
10603295022763	P830055	093
10603295022732	P830055	093
10603295022817	P830055	093
10603295022800	P830055	093
10603295022749	P830055	093
10603295022756	P830055	093
10603295022787	P830055	093
10603295022770	P830055	093
10603295022794	P830055	093
10603295022442	P830055	093
10603295022589	P830055	093
10603295022572	P830055	093
10603295022565	P830055	093
10603295022558	P830055	093
10603295022541	P830055	093
10603295022534	P830055	093
10603295022527	P830055	093
10603295022510	P830055	093
10603295022503	P830055	093
10603295022497	P830055	093
10603295022480	P830055	093
10603295022473	P830055	093
10603295022466	P830055	093
10603295022459	P830055	093
10603295022596	P830055	093
10603295022602	P830055	093
10603295022725	P830055	093
10603295022701	P830055	093
10603295022695	P830055	093
10603295022688	P830055	093
10603295022671	P830055	093
10603295022664	P830055	093
10603295022657	P830055	093
10603295022640	P830055	093
10603295022633	P830055	093
10603295022626	P830055	093
10603295022619	P830055	093
10603295022718	P830055	093
10603295232810	P830055	099
10603295232797	P830055	099
10603295074816	P830055	099
10603295232803	P830055	099
10603295074809	P830055	099
10603295232780	P830055	099
10603295076292	P830055	106
10603295076285	P830055	106
10603295076278	P830055	106
10603295076261	P830055	106
10603295076254	P830055	106
10603295076247	P830055	106
10603295076230	P830055	106
10603295076308	P830055	106
10603295076315	P830055	106
10603295076322	P830055	106
10603295076339	P830055	106
10603295076346	P830055	106
10603295076353	P830055	106
10603295076360	P830055	106
10603295076377	P830055	106
10603295076384	P830055	106
10603295076391	P830055	106
10603295076223	P830055	106
10603295076216	P830055	106
10603295076056	P830055	106
10603295076063	P830055	106
10603295076070	P830055	106
10603295076087	P830055	106
10603295076094	P830055	106
10603295076100	P830055	106
10603295076117	P830055	106
10603295076124	P830055	106
10603295076131	P830055	106
10603295076148	P830055	106
10603295076155	P830055	106
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