FDA.reportPublic FDA data

DEPUY INTL., LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80103791000199976DEPUY INTL., LTD.1N2027-01-01ST. ANTHONYS RD. LEEDS GB LS11 8DT

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
38271948204226P960054S-ROM POLY-DIAL CONSTRAINED LINERKWZ1997-06-19
38271494980439P830055LCS(R) TOTAL KNEE SYSTEMNJL1985-04-12
38271187822846K994415MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERSLPH2000-02-03
38271537633783K982918DEPUY C-STEM SYSTEMJDI1998-10-05
38271247773483K980513ARTICUL/EZE FEMORAL HEADSJDI1998-04-14
38271980342022K972596DEPUY DURALOC ACETABULAR CUP SYSTEMLPH1997-11-12
38271833062145K971682J-FX CERCLAGE SYSTEMLRN1997-06-27
38271681659710K965156ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVESKWL1997-01-24
38271294030848K964795CEMENTED CALCAR REPLACEMENT FEMORAL STEMJDI1997-02-19
38271993962203K961186DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEMLPH1996-09-17
38271310202430K955385JOHNSON & JOHNSON AUSTIN MOORE STEMKWL1996-01-30
38271087800004K953694DEPUY VISION AML HIP PROTHESISLPH1996-02-01
38271440057532K952740DEPUY DURALOC 400 ACETABULAR CUPLPH1995-08-18
38271383007550K940743UHMWPE COMPONENTS-CHANGE IN PACKAGINGKWY1995-09-18
38271250058780K931189P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACETLZO1994-02-09
38271086532724K930712P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULARLZO1993-10-04
38271985375614K924492POLY-DIAL INSERTSLPH1992-11-24
38271432407521K920317S-ROM LF FEMORAL HEADJDI1992-03-19
38272065211506K903084MODULAR CATHCART FRACTURE SYSTEMLZY1990-10-03
38271053787225K902395MODIFIED AML + ACETABULAR CUP SYSTEMJDI1990-08-24
38271945910162K902137P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENTJDI1990-06-26
38271367800818K900832MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA.JDI1990-05-04
38272066035988K900638P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENTKWL1990-04-30
38272069268311K893872P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENTKWY1989-09-11
38271788653275K884796P.F.C.(TM) MODULAR KNEE SYSTEMJWH1989-03-29
38271727136498K883460FOCUS TOTAL HIP SYSTEMJDI1988-10-11
38271526157052K882234JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESISJWH1988-10-20
38271859150052K873585POROUS COATED ACETABULAR CUPJDI1987-10-28
38271134863612K871867ELITE MODULAR HIP SYSTEMJDI1988-04-08
38271869920454K870271S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUPKWZ1987-04-20
38271025492195K860701HPS II SMOOTH STEMJDI1986-03-19
38271660197784K853655NEW JERSEY MODULAR FEMORAL HIPJDI1985-09-19
38271203479195K851422S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIPJDI1985-09-18
38271397924578K851421S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIPLPH1985-06-04
38271532586721K843909TITANIUM HIP 1019JDI1984-11-15
38271727111246K802627ORTRON 90* HIP PROSTHESISJDI1980-12-16
38271697222625K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementKWL2026-05-15
38271996316742K251292RECLAIM Monobloc Revision Femoral StemLZO2025-05-23
38271597881175K240639PINNACLETM Constrained Acetabular LinersKWZ2024-04-04
38271836558053K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR ConditionalMEH2024-01-19
38271467145665K231526CORAIL Cemented Femoral StemKWY2023-12-19
38271853508784K222296ARTICUL/EZE Ceramic HeadsLZO2023-01-06
38271751817019K221462DePuy Reclaim Monobloc Revision Femoral StemLZO2022-10-21
38271024296391K220216
38271482810717K203532BI-MENTUM™ ALTRX® Dual Mobility LinerLZO2021-04-28
38271419104294K200854DePuy PINNACLE Dual Mobility LinerLPH2020-09-11
38271628440586K140881DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETSMBH2015-02-13
38271402058729K120599DEPUY M-SPEC 36MM FEMORAL HEADSLPH2013-04-30
38271466477909K102423DEPUY PINNACLE ALTRX ACETABULAR LINERSLPH2010-10-29
38271491703285K101996DEPUY GLOBAL UNITE SHOULDER SYSTEMPHX2010-12-15
38271791707025K093736DEPUY CORAIL HIP SYSTEM, REVISION STEMLZO2011-03-10
38271845139393K082585DEPUY ASPHERE M-SPEC HEADKWA2008-12-04
38271914445203K082239DEPUY C-STEM AMTJDI2008-08-29
38271340666164K072963DEPUY PINNACLE ALTRX ACETABULAR LINERSLPH2008-01-09
38271946348646K070554DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESISLZO2007-09-11
38271673378657K062148DEPUY PINNACLE ALTRX ACETABULAR CUP LINERLPH2006-10-24
38272003668800K060031DEPUY MODULAR M HEADSLPH2006-01-31
38271378734570K043223DEPUY CAS KNEE INSTRUMENTATIONHAW2005-03-04
38271964353665K042992CORAIL AMT HIP PROSTHESISLZO2005-02-11
38271225621081K042959DEPUY C-STEM AMT HIP PROSTHESISJDI2004-12-22
38271543773774K040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062LPH2004-05-28
38271628457430K040383TRIFLANGE II ACETABULAR CUP SYSTEMLPH2004-05-12
38271789053766K013350MODIFICATION TO DEPUY C-STEM SYSTEMJDI2001-11-07
38271527969190K003421DEPUY C-STEM SYSTEMJDI2000-12-01
38271180146239K001277TRIFLANGE ACETABULAR CUP SYSTEMLPH2000-06-23
38271002379245
38271005126228
38271030448231
38271081022463
38271085776252
38271111573509
38271174317442
38271213597389
38271213929095
38271251053747
38271255393883
38271270941603
38271271537837
38271280810349
38271306976916
38271312089002
38271355302436
38271358651161
38271380944911
38271385863193
38271400898936
38271424947010
38271444517448
38271448068685
38271456739312
38271456909949
38271466837280
38271490090988
38271500585269
38271509754406
38271525362594
38271565167115
38271630053497
38271670381034
38271722997311
38271770519975
38271794710644
38271799913671
38271844758729
38271859452779
38271867311197
38271868599290
38271894935199
38271900624889
38271913940363
38271946904971
38271981460936
38272006640480
38272017727995
38272019780875
38272044488144
38272067491701

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JDI192008-08-29
LPH162020-09-11
LZO92025-05-23
KWL42026-05-15
KWY32023-12-19
KWZ22024-04-04
JWH21989-03-29
MEH12024-01-19
MBH12015-02-13
PHX12010-12-15
KWA12008-12-04
HAW12005-03-04
LRN11997-06-27
KWZ 11997-06-19
LZY11990-10-03
NJL11985-04-12

PMN#