ZIMMER, INC.

Matched from indexed company URL: Zimmer, Inc.

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1822565	1000220733	ZIMMER, INC.	1	Y	2026-01-01	1800 W. Center Street WARSAW IN US 46580

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
3870	2021225455	P060037	NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM	NJL	2007-12-10
3870	1305223560	N17755	ZIMMER(R) BONE CEMENT	LOD	1976-05-17
3870	1050060098	K994286	ZMR HIP SYSTEM-POROUS REVISION	LPH	2000-03-10
3870	1879211623	K993259	INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS	LPH	2000-03-10
3870	1957938625	K992667	ZMR HIP SYSTEM-REVISION TAPER	LPH	1999-10-27
3870	1321022132	K991581	NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO	JWH	1999-07-30
3870	1115836957	K991143	MAGNA-ROM 21 KNEE SYSTEEM	JWH	1999-06-11
3870	1415906026	K990135	TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE	LPH	1999-07-12
3870	1297342281	K983509	INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT	LPH	1999-02-03
3870	1967241408	K983153	NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS	JWH	1998-12-04
3870	1823548274	K982981	NEW ZIMMER SHOULDER SYSTEM	KWT	1998-12-17
3870	1027126450	K982903	SULZER ORTHOPEDICS FLUTED STEMS	JWH	1998-10-21
3870	1108471105	K980711	HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING	LPH	1998-11-12
3870	1554036053	K973714	VERSYS HIP SYSTEM BEADED HIP PROSTHESIS	LPH	1997-12-24
3870	1167824763	K973681	NATURAL-HIP COCR OFFSET STEM	LZO	1997-12-19
3870	1842638096	K973675	NATURAL-HIP POROUS STEM WITH OFFSET	LPH	1997-12-19
3870	1261322436	K973412	NATURAL-KNEE II CONSTRAINED KNEE SYSTEM	JWH	1997-12-08
3870	1653375815	K973357	COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN	JDC	1998-03-02
3870	1474459011	K973124	APR POROUS HA HIP SYSTEM	LPH	1997-11-03
3870	1810922054	K973087	MOST HEX INTRAMEDULLARY (I/M) STEM	LZO	1997-11-14
3870	1450054690	K972774	GAS PLASMA STERILIZATION	JWH	1999-05-05
3870	1525079570	K972637	PRECEDENT REVISION HIP SYSTEM	LZO	1997-10-01
3870	1539557603	K972501	APOLLO REVISION/CONSTRAINED KNEE SYSTEM	JWH	1997-10-01
3870	1723329471	K972393	INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)	LPH	1997-09-19
3870	2014574437	K971770	APOLLO KNEE FEMORAL SPACERS	JWH	1997-07-31
3870	1417577561	K971715	SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS	KWS	1997-08-07
3870	1150343715	K970706	INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES	LPH	1997-05-22
3870	1921852707	K970705	INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES	LPH	1997-05-22
3870	1024924832	K970498	NATURAL-KNEE II REVISION FEMORAL SPACER LUGS	JWH	1997-04-30
3870	1313288297	K970300	NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI	LPH	1997-07-03
3870	1529083176	K970166	NATURAL-HIP SYSTEM COCR REVISION STEM	LZO	1997-04-08
3870	1747797187	K965098	INTRAMEDULLARY NAIL SYSTEM	HSB	1997-02-28
3870	1545785504	K964769	VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS	LPH	1997-02-13
3870	1923020199	K964350	MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA	JDI	1997-01-16
3870	1639454851	K963266	NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED	LPH	1996-10-15
3870	1374371984	K963155	INTERMOORE FRACTURE HIP STEM (MODIFY)	LWJ	1996-10-01
3870	1671992285	K963148	NEXGEN COMPLETE KNEE SOLUTION	JWH	1997-02-13
3870	1909152658	K963109	HERITAGE HIP SYSTEM	JDI	1997-01-09
3870	1744641988	K962561	SUPRACONDYLAR INTRAMEDULLARY NAIL	HSB	1996-09-25
3870	1624360001	K962468	HEDROCEL ACETABULAR RESTRICTOR	JDI	1997-02-03
3870	1559673437	K962315	SELECT SHOULDER COCR HUMERAL STEM COMPONENT	KWT	1996-09-03
3870	1157708277	K962289	SELECT SHOULDER COCR HUMERAL STEM COMPONENT	HSD	1996-08-29
3870	1110940756	K962238	SELECT SHOULDER KEELED ALL-POLY GLENOIDS	KWT	1996-08-09
3870	1586580948	K962224	SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS	KWS	1996-08-28
3870	1809196288	K962196	NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESS	JWH	1996-08-23
3870	1873833157	K961921	APR OVERSIZED HIP STEM	LZO	1996-08-05
3870	1875853876	K961799	NATURAL HIP SYSTEM - DRG HIP STEM	JDI	1996-07-15
3870	2045076325	K961589	APR FULLY TEXTURED HIP STEM	LZO	1996-07-09
3870	1795779945	K961378	DELTA HIP PROSTHESIS	LWJ	1996-10-08
3870	1360804174	K960658	COLLARLESS POLISHED TAPER HIP PROSTHESIS	JDI	1996-07-16
3870	1017795352	K960626	MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)	JDI	1996-04-18
3870	1243785628	K960279	NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES	JWH	1996-04-26
3870	1357134432	K960278	COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT	JDI	1996-07-25
3870	1542286208	K960258	NATURAL HIP SYSTEM	JDI	1996-07-12
3870	1110390709	K955778	NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM	HRY	1996-03-08
3870	1529892216	K955739	MODULAR ACETABULAR SHELL II	LPH	1996-03-27
3870	1999825771	K955473	GAMMA SYSTEM	JDI	1996-02-16
3870	1545355539	K955033	RIM FLARE ACETABULAR COMPONENT	LPH	1996-01-31
3870	1432914507	K954854	INTERMOORE FRACTURE HIP STEM	LWJ	1996-02-15
3870	1769582870	K954800	APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)	MEH	1996-04-25
3870	1241544167	K954744	ZCH ALPHA SYSTEM	JDI	1996-01-23
3870	1462961650	K954698	TRILOGY ACETABULAR COMPONENT 7MM OFFSET	LPH	1996-01-17
3870	1918044608	K954555	VERSA-FX FEMORAL FIXATION SYSTEM	KTT	1996-01-26
3870	1674092034	K953490	TRILOGY ACETABULAR SHELL & LINERS 36MM	LPH	1995-10-20
3870	1245048353	K953337	BETA HIP PROSTHESIS	LPH	1996-01-22
3870	1674694090	K952776	LFIC OR FETTO HIP	LWJ	1996-02-14
3870	1991125438	K951185	NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE	JWH	1996-03-15
3870	1263871447	K950998	MODUILAR UNIPOLAR	KXA	1995-04-13
3870	1497095662	K950312	ALPHA SYSTEM	JDI	1995-05-17
3870	1891985934	K946150	CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)	JWH	1995-07-11
3870	1777883184	K945516	NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM	LZO	1995-02-14
3870	1069695444	K944209	APR II NON POROUS HIP STEM	LZO	1994-12-09
3870	1256714863	K942330	APR II FEMORAL COMPONENT (VARIOUS)	LZO	1994-10-04
3870	1401664501	K942263	MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM	HSX	1995-07-11
3870	1762451965	K941617	APR ACETABULAR INSERT	JDI	1994-10-06
3870	1272505592	K941213	SONGER CABLE SYSTEM	JDQ	1994-04-19
3870	1061679470	K936159	NATURAL-KNEE II SYSTEM	JWH	1995-05-22
3870	1277882180	K935789	POSTERIOR STABILIZED APOLLO KNEE SYSTEM	JWH	1995-02-06
3870	1283177322	K934765	TRILOGY ACETABULAR SYSTEM	LPH	1994-04-29
3870	1109991901	K934695	NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA	JWH	1996-05-02
3870	1997603397	K934381	APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT	JWH	1995-02-08
3870	1725557653	K933785	NEXT GENERATION KNEE SYSTEM	JWH	1995-01-30
3870	1144650666	K933229	APOLLO KNEE FEMORAL COMPONENT	JWH	1995-01-27
3870	1785412651	K933203	APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP	LZO	1994-04-19
3870	1475237859	K931651	NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW	JWH	1994-07-18
3870	1578930181	K930831	MG II POROUS KNEE SYSTEM FEMORAL COMPONENTS	JWH	1993-11-16
3870	2055377016	K930812	APR FEMORAL HIP COMPONENT	JDI	1993-11-17
3870	1555238842	K930554	THE NATURAL-KNEE REVISION	JWH	1993-09-21
3870	1441389187	K925242	APOLLO(TM) KNEE SYSTEM	JWH	1993-06-04
3870	2004510251	K922952	SONGER CABLE SYSTEM	JDQ	1993-02-23
3870	1644470469	K922071	ZIMMER ANATOMIC HIP SYSTEM	LPH	1994-02-22
3870	1665574744	K921308	HG MULTILOCK HIP PROSTHESIS W/ TI-NIDIUM	LPH	1994-02-22
3870	1547776614	K920955	APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE	LPH	1994-02-09
3870	1827621916	K913649	MODULAR CALCAR REPLACEMENT	JDI	1991-11-13
3870	1367560483	K913634	APR II HIP SYSTEM	JDI	1991-12-16
3870	1697969930	K913561	LUQUE SEGMENTAL SPINAL INSTRUMENTATION	KWP	1992-01-16
3870	1127293390	K913208	APR II NON-POROUS HIP STEM	JDI	1991-10-11
3870	1104582824	K913060	NATURAL POROUS HIP SYSTEM	JDI	1991-10-11
3870	1317115729	K911572	MG II POROUS COBAL T-CHROME FEMORAL COMPONENT	JWH	1991-07-01
3870	1667097293	K905781	APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM	MEH	1991-03-04
3870	1172157329	K902335	NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM)	JWH	1990-08-22
3870	1137092669	K901240	ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED	JDI	1990-03-26
3870	1157598449	K894051	PREMIER-TOTAL HIP	LWJ	1989-08-28
3870	1436064914	K892800	MG II POROUS TOTAL KNEE SYSTEM	JWH	1989-08-03
3870	1003730261	K892228	INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM	HRS	1989-10-06
3870	1582269886	K884943	INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID	KWS	1989-04-27
3870	1353499293	K883969	UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM	HRY	1989-04-19
3870	1223747915	K883665	COONRAD III TOTAL ELBOW	JDC	1989-02-03
3870	1920511293	K881836	INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP	KWS	1988-08-29
3870	1693841805	K880155	MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE	HSX	1988-08-03
3870	1440158226	K873999	PREMIER-TOTAL (TM) HIP	JDI	1987-10-28
3870	1957828478	K873679	SELECT SHOULDER SYSTEM	HSD	1987-11-17
3870	1173605204	K872379	INSALL/BURSTEIN* II MODULAR TOTAL KNEE	JWH	1987-10-28
3870	2007656104	K872019	BI-ARTICULAR II HIP DEVICE	KWY	1987-07-21
3870	1337639124	K862632	INSALL/BURSTEIN(TM)* II TIBIAL WEDGES	HSX	1987-03-25
3870	1726822073	K853991	HOFMANN KNEE	JWH	1986-02-21
3870	1645113493	K853661	MILLAR/GALANTE PRECOATED TOTAL KNEE	JWH	1985-12-09
3870	1866242155	K853524	APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT	KMC	1985-11-22
3870	1855398303	K850770	INTERMEDICS BONE SCREW	HWC	1985-04-19
3870	1621160284	K850766	ZIMMER THREADED ACETABULAR CUP	KWA	1985-05-01

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
JWH	72	2025-03-06
LPH	59	2026-02-04
JDI	35	2025-07-31
LZO	27	2026-04-27
HRS	25	2016-01-28
MBH	20	2026-03-09
HSB	16	2026-03-12
HWC	12	2015-11-24
KWT	11	2019-06-05
KTT	11	2015-12-30
PHX	9	2024-05-15
HSX	8	2020-03-17
JDC	8	2019-01-28
KWS	7	2020-02-24
KWA	7	2011-10-07
KRO	6	2015-02-06
LWJ	6	2000-11-15
MBF	5	2026-04-13
KWZ	5	2010-12-03
QHE	4	2023-12-12
JDQ	4	2016-01-15
KWY	4	2004-08-27
HRY	3	2004-03-05
HTY	2	2015-05-01
HSD	2	1996-08-29
MEH	2	1996-04-25
KWP	2	1992-01-16
PKC	1	2024-12-11
PBI	1	2022-04-28
HSN	1	2012-08-24
OQG	1	2012-06-04
HTN	1	2009-09-11
JDL	1	2008-08-07
NJL	1	2007-12-10
KRR	1	2007-06-07
HSH	1	2001-01-04
KXA	1	1995-04-13
KMC	1	1985-11-22
JDR	1	1982-01-12
KWL	1	1981-08-12

PMA

NexGen® LPS-Flex/LPS Mobile Bearing Knee System

2022-10-06

ZIMMER, INC.p.o. Box 708warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS082 Date Received09/30/2022 Decision Date10/06/2022 Product Code NJL Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacture...

NexGen® LPS-Flex / LPS-Mobile Bearing Knee

2022-08-15

ZIMMER, INC.p.o. Box 708warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS080 Date Received07/25/2022 Decision Date08/15/2022 Product Code NJL Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change ...

NexGen LPS-Flex/ LPS-Mobile Bearing Knee

2022-05-20

ZIMMER, INC.p.o. Box 708warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS079 Date Received05/09/2022 Decision Date05/20/2022 Product Code NJL Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacture...

NexGen LPS-Flex/ LPS-Mobile Bearing Knee System

2022-03-23

ZIMMER, INC.p.o. Box 708warsaw, IN 46581-0708 PMA NumberP060037 Supplement NumberS078 Date Received03/07/2022 Decision Date03/23/2022 Product Code NJL Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacture...