DEPUY ORTHOPAEDICS, INC.

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1219655	1219655	DEPUY ORTHOPAEDICS, INC.	1	N	2026-01-01	325 PARAMOUNT DR. RAYNHAM MA US 02767
1818910	1818910	DEPUY ORTHOPAEDICS, INC.	1	N	2026-01-01	700 ORTHOPAEDIC DR. WARSAW IN US 46582

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
3823	1948204226	P960054	S-ROM POLY-DIAL CONSTRAINED LINER	KWZ	1997-06-19
3823	1669817977	P910016	New Jersey Lcs(r) Total Knee System		1992-10-30
3815	1494980439	P830055	LCS(R) TOTAL KNEE SYSTEM	NJL	1985-04-12
3823	1494980439	P830055	LCS(R) TOTAL KNEE SYSTEM	NJL	1985-04-12
3823	1552687517	P090002	PINNACLE COMPLETE ACETABULAR HIP SYSTEM	OVO	2011-06-13
3823	1056179924	P070026	CERAMAX CERAMIC HIP SYSTEM	MRA	2010-12-23
3823	1187822846	K994415	MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS	LPH	2000-02-03
3823	1419374980	K992656	DEPUY TOTAL ELBOW SYSTEM	JDC	1999-11-05
3823	1013553564	K992065	GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD	KWS	1999-07-12
3815	1659907198	K991106	P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY	JWH	1999-06-09
3823	1659907198	K991106	P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY	JWH	1999-06-09
3823	1733202644	K984541	GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD	KWT	1999-01-14
3815	1765533450	K984158	P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY	JWH	1999-01-28
3823	1765533450	K984158	P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY	JWH	1999-01-28
3823	1505911296	K983491	DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER	LPH	1998-12-02
3823	1436306779	K983141	CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS	JDB	1998-11-06
3815	1436306779	K983141	CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS	JDB	1998-11-06
3815	1548828976	K983014	SUMMIT ACETABULAR SYSTEM	LPH	1998-10-27
3823	1548828976	K983014	SUMMIT ACETABULAR SYSTEM	LPH	1998-10-27
3823	1619094274	K982347	DEPUY ACE TIMAX PILON PLATE	HRS	1998-08-31
3823	1830972751	K982330	DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT	FTM	1998-09-25
3823	2028179372	K981487	DEPUY GLOBAL SHOULDER GLENOID	KWS	1998-07-13
3823	1247773483	K980513	ARTICUL/EZE FEMORAL HEADS	JDI	1998-04-14
3823	1108390739	K974740	DEPUY TRI-LOCK HIP STEM	LPH	1998-03-18
3823	1088982226	K972832	PROVISION SURGICAL HELMET SYSTEM	FYA	1997-10-21
3823	1851889533	K972643	DEPUY AMK 3 PEG PATELLA	JWH	1998-01-21
3823	1980342022	K972596	DEPUY DURALOC ACETABULAR CUP SYSTEM	LPH	1997-11-12
3823	1833062145	K971682	J-FX CERCLAGE SYSTEM	LRN	1997-06-27
3823	1292646169	K971652	P.F.C. SIGMA INSET PATELLA	JWH	1997-07-16
3815	1292646169	K971652	P.F.C. SIGMA INSET PATELLA	JWH	1997-07-16
3815	1250351392	K971189	P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)	JWH	1997-07-17
3823	1250351392	K971189	P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)	JWH	1997-07-17
3823	1336397813	K971070	SCARF THREAD-HEAD (TM) HEAD SCREW	HWC	1997-07-09
3823	1554964077	K971068	34MM SCARF THREAD-HEAD(TM) SCREW	HWC	1997-07-09
3815	1820848018	K970929	DEPUY LOW PROFILE BONE SCREW	HWC	1997-06-09
3823	1820848018	K970929	DEPUY LOW PROFILE BONE SCREW	HWC	1997-06-09
3823	1739529414	K970544	DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS	KYJ	1997-09-12
3823	1294030848	K964795	CEMENTED CALCAR REPLACEMENT FEMORAL STEM	JDI	1997-02-19
3823	1332548245	K964114	DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS	FXX	1997-05-06
3823	1745144948	K963309	APEX HOLE ELIMINATOR PS	LPH	1996-11-12
3815	1012943645	K963206	S-ROM HIP SYSTEM - LOCKING PLUG	JDI	1996-10-17
3823	1012943645	K963206	S-ROM HIP SYSTEM - LOCKING PLUG	JDI	1996-10-17
3815	1249024695	K963117	P.F.C. CRUCIATE RETAING KNEE SYSTEM	JWH	1996-11-06
3823	1249024695	K963117	P.F.C. CRUCIATE RETAING KNEE SYSTEM	JWH	1996-11-06
3815	1447459534	K962007	PROTRUSION CAGES	JDJ	1996-08-01
3823	1447459534	K962007	PROTRUSION CAGES	JDJ	1996-08-01
3823	1120079518	K961732	KAR	MEH	1997-07-08
3815	1238752491	K961685	P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)	JWH	1996-07-10
3823	1238752491	K961685	P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)	JWH	1996-07-10
3823	1353955474	K961619	DEPUY ENDURANCE CALCAR HIP PROSTHESIS	JDI	1996-07-12
3823	1013891080	K961239	DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL	FYA	1996-09-17
3823	1993962203	K961186	DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM	LPH	1996-09-17
3823	1861052911	K955884	COORDINATE REVISION KNEE SYSTEM	JWH	1996-03-13
3815	1861052911	K955884	COORDINATE REVISION KNEE SYSTEM	JWH	1996-03-13
3823	1316430613	K955511	ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP	LPH	1996-02-26
3815	1310202430	K955385	JOHNSON & JOHNSON AUSTIN MOORE STEM	KWL	1996-01-30
3823	1560708369	K954684	DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT	JWH	1996-01-26
3823	1009221526	K954481	P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM	HRY	1996-10-10
3815	1009221526	K954481	P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM	HRY	1996-10-10
3823	1121092894	K953703	DEPUY VISION SOLUTION HIP PROSTHESIS	LPH	1996-02-01
3823	1087800004	K953694	DEPUY VISION AML HIP PROTHESIS	LPH	1996-02-01
3815	1087800004	K953694	DEPUY VISION AML HIP PROTHESIS	LPH	1996-02-01
3823	1791739443	K953111	CORAIL	LZO	1996-12-27
3823	1103710533	K952859	ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT	JDI	1996-01-31
3815	1611837498	K952830	DARWIN KNEE SYSTEM (TC3)	JWH	1996-01-18
3823	1611837498	K952830	DARWIN KNEE SYSTEM (TC3)	JWH	1996-01-18
3823	1440057532	K952740	DEPUY DURALOC 400 ACETABULAR CUP	LPH	1995-08-18
3823	1527978462	K951674	DEPUY DURALOC 100C ACETABULAR CUP	LPH	1995-05-11
3823	1204430595	K951301	DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM	LPH	1995-04-18
3823	1316399517	K951000	ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM	LPH	1995-04-14
3815	1316399517	K951000	ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM	LPH	1995-04-14
3823	1359870674	K950563	ULTIMA AUGMENTED UHMWPE CUP	KWL	1995-06-07
3815	1941211282	K950010	DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED	JWH	1995-05-15
3823	1941211282	K950010	DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED	JWH	1995-05-15
3823	1577246738	K944538	GAS PLASMA STERILIZATION	HRY	1995-09-26
3815	1577246738	K944538	GAS PLASMA STERILIZATION	HRY	1995-09-26
3823	1437202582	K944132	P.F.C. TOTAL HIP SYSTEM	KWY	1995-01-06
3823	1491511371	K943727	BIOSTOP G BONE CEMENT RESTRICTOR	LZN	1995-05-11
3823	1409362829	K943696	ALL POLYETHYLENE CEMENTED ACETABULAR CUP	JDI	1995-05-17
3815	1130397448	K943462	DARWIN KNEE SYSTEM	JWH	1994-12-21
3823	1130397448	K943462	DARWIN KNEE SYSTEM	JWH	1994-12-21
3823	1122409492	K943299	DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY	JWH	1995-01-27
3823	1292077025	K942370	DEPUY CEMENTED HIP PROSTHESIS	JDI	1994-11-10
3815	1021597044	K941769	KNEE PROTHESIS	JWH	1995-02-01
3823	1021597044	K941769	KNEE PROTHESIS	JWH	1995-02-01
3823	1383007550	K940743	UHMWPE COMPONENTS-CHANGE IN PACKAGING	KWY	1995-09-18
3823	1790381930	K936037	S-ROM NOILES CRUCIATE RETAINING KNEE	JWH	1994-10-03
3815	1790381930	K936037	S-ROM NOILES CRUCIATE RETAINING KNEE	JWH	1994-10-03
3823	1569141849	K935262	P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA	JWH	1994-06-03
3815	1569141849	K935262	P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA	JWH	1994-06-03
3823	1776902652	K934557	CONTROL CABLE SYSTEM	JDQ	1994-02-25
3823	1885191532	K933275	P.F.C. CERAMIC HIP HEAD	LZO	1994-09-28
3815	1143353850	K931676	S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG	JDL	1994-05-18
3823	1143353850	K931676	S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG	JDL	1994-05-18
3823	1491429671	K931652	ACE 6.5 MM BONE SCREW	HWC	1994-04-28
3823	1485492188	K931641	POROCOAT POROUS COATING	LPH	1994-03-21
3823	1250058780	K931189	P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET	LZO	1994-02-09
3823	1086532724	K930712	P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR	LZO	1993-10-04
3823	1341581784	K925025	PRISM BONE CEMENT MIXING SYSTEM	JDZ	1994-01-05
3823	1636173501	K924940	FEMORAL & TIBIAL AUGMENT BLOCK	JWH	1993-03-09
3815	1636173501	K924940	FEMORAL & TIBIAL AUGMENT BLOCK	JWH	1993-03-09
3823	1985375614	K924492	POLY-DIAL INSERTS	LPH	1992-11-24
3823	1282716600	K924340	P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT	JWH	1994-01-25
3815	1282716600	K924340	P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT	JWH	1994-01-25
3823	1273088891	K924115	ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS	JDI	1992-11-24
3823	1460409753	K923807	P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS	JWH	1992-11-09
3815	1460409753	K923807	P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS	JWH	1992-11-09
3815	2058457491	K922824	KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM	HSX	1992-09-17
3823	2058457491	K922824	KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM	HSX	1992-09-17
3823	1760235917	K920802	ALVINE TOTAL ANKLE	HSN	1992-12-17
3823	1432407521	K920317	S-ROM LF FEMORAL HEAD	JDI	1992-03-19
3823	1055691387	K920286	DEPUY TOTAL HIP BALLS - ION IMPLANTATION	JDI	1992-04-21
3823	1137599682	K914702	STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS	FXP	1993-01-29
3823	1620467695	K914694	STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU	JCX	1992-01-16
3823	1491683082	K914077	REPEL(TM) LITE CUT RESISTANT GLOVE LINERS	LYU	1991-12-02
3823	1755568916	K914000	GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE	KWT	1991-12-04
3823	1194996645	K912713	S-ROM ZT HA PROXIMAL FEMORAL SLEEVE	MEH	1991-12-30
3823	1047714914	K910992	AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE	JWH	1992-08-10
3823	1104347772	K910941	LIFELINER SURGICAL GLOVE	FYE	1991-05-09
3823	1181400812	K910940	ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY	JWH	1991-09-10

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
JWH	78	2021-08-25
LPH	55	2025-01-22
JDI	34	2009-12-17
PHX	21	2026-03-11
LZO	19	2023-01-06
HRY	12	2020-04-16
KRO	10	2024-11-21
KWS	9	2014-04-03
MBH	8	2024-06-18
MEH	8	2024-01-19
MQV	7	2025-10-22
KWZ	7	2024-04-04
MBF	7	2023-11-13
OIY	6	2024-11-01
HAW	6	2007-05-23
HWC	6	1997-07-09
HSB	6	1988-12-01
OLO	4	2024-06-14
HSN	4	2012-10-31
HSD	4	2008-12-18
FTM	4	2007-09-04
NPJ	4	2007-06-26
KWL	4	1996-01-30
PKC	3	2024-12-23
LLZ	3	2023-08-22
KYJ	3	2009-02-09
JDC	3	2006-04-14
KWT	3	1999-01-14
FYA	3	1997-10-21
KWY	3	1995-09-18
LYU	3	1991-12-02
FMF	2	2025-06-24
KWA	2	2008-12-04
LWJ	2	2003-02-05
JDB	2	1998-11-06
JDJ	2	1996-08-01
JDL	2	1994-05-18
HSX	2	1992-09-17
HTN	2	1991-07-24
JEC	2	1990-01-11

PMA

CERAMAX Ceramic Total Hip System

2022-12-08

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS103 Date Received11/28/2022 Decision Date12/08/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

CERAMAX® Ceramic Total Hip System

2022-10-04

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS102 Date Received09/07/2022 Decision Date10/04/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

CERAMAX® Ceramic Total Hip System

2022-08-26

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS101 Date Received07/28/2022 Decision Date08/26/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

CERAMAX® Ceramic Total Hip System

2022-07-12

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS100 Date Received07/01/2022 Decision Date07/12/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

Ceramax Ceramic Total Hip System

2022-06-07

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS098 Date Received05/09/2022 Decision Date06/07/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

CERAMAX® Ceramic Total Hip System

2022-05-05

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS097 Date Received04/07/2022 Decision Date05/05/2022 Product Code MRA Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason ...

CERAMAX Ceramic Total Hip System

2022-04-14

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS096 Date Received04/06/2022 Decision Date04/14/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

Ceramax® Ceramic Total Hip System

2022-03-22

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS094 Date Received02/22/2022 Decision Date03/22/2022 Product Code MRA Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason ...

CERAMAX Total Hip System

2022-03-10

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS093 Date Received02/14/2022 Decision Date03/10/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

CERAMAX® Ceramic Total Hip System

2022-02-22

DEPUY ORTHOPAEDICS, INC.700 Orthopaedic Drivewarsaw, IN 46582 PMA NumberP070026 Supplement NumberS091 Date Received02/11/2022 Decision Date02/22/2022 Product Code MRA Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Chan...

DEPUY ORTHOPAEDICS, INC.

FDA Registration(s)

Registered Device Listings

Product Codes Associated With Registrations

PMA

PMN

Applications

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