Data / Medical devices / Ireland / Depuy (ireland)
Depuy (ireland): FDA-registered device maker in CO. CORK Munster, Ireland, 87 510(k) clearances and 3 PMA approvals
Depuy (ireland) is registered with the FDA (registration 9616671) in CO. CORK Munster, Ireland. It lists 75 device types. The FDA files 87 510(k) clearances and 3 PMA approvals under its listings, the newest dated January 19, 2024. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 9616671
- FEI number
- 3002854251
- Address
- Loughbeg Ringaskiddy, CO. CORK Munster, Ireland, --
- Owner or operator
- DePuy Synthes, Inc. (1818910)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 22, 1977
- Registered through
- 2027
- Brand names listed
- ARICULATED TENSION DEVICE SYNTHES TEN, ASphere (hip), M-Spec, ATTUNE REV FB INSERT IMPACTOR, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 3, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 4, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 5, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 6, ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 7 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 19, 2024 | K231873 | DePuy 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 Conditional | MEH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 19, 2022 | K212683 | GLOBAL ICON Stemless Shoulder System | PKC | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| January 6, 2022 | K213839 | DePuy Corail AMT Hip Prosthesis | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| April 2, 2021 | K203230 | Global Shoulder and Delta CTA systems | KWS | Substantially Equivalent | Depuy Lnc. | accessdata.fda.gov |
| October 21, 2020 | K202472 | ACTIS Duofix Hip Prosthesis | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 4, 2020 | K193398 | Summit DuoFix HA Coating | MEH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 1, 2019 | K190344 | DePuy Corail AMT Hip Prosthesis | LZO | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| October 4, 2019 | K192448 | Delta Xtend Revers Shoulder System | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| September 21, 2018 | K173960 | DePuy Corail AMT Hip Prosthesis | LZO | Substantially Equivalent | Depuy France S.A.S. | accessdata.fda.gov |
| January 11, 2018 | K170748 | GLOBAL UNITE Platform Shoulder System | PHX | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| June 15, 2017 | K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing | JWH | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| July 19, 2016 | K160907 | DePuy Actis DuoFix Hip Prosthesis | MEH | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| June 10, 2016 | K160700 | ATTUNE Revision Knee System | JWH | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| September 25, 2015 | K150862 | DePuy Actis Duofox Hip Prosthesis | MEH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 13, 2015 | K140881 | DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS | MBH | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| April 3, 2014 | K133834 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | KWS | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| April 30, 2013 | K120599 | DEPUY M-SPEC 36MM FEMORAL HEADS | LPH | Substantially Equivalent | Depuy Orthopaedics | accessdata.fda.gov |
| September 6, 2012 | K122442 | DEPUY CTA REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Depuy France | accessdata.fda.gov |
| June 11, 2012 | K120174 | DEPUT DELTA XTEND REVERSE SHOULDER | PHX | Substantially Equivalent | Depuy France | accessdata.fda.gov |
| August 30, 2011 | K111433 | DEPUY STTUNE (TM) PS KNEE SYSTEM | OIY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 15, 2011 | K103756 | DEPUY ATTUNE TOTAL KNEE SYSTEM | OIY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 15, 2010 | K101996 | DEPUY GLOBAL UNITE SHOULDER SYSTEM | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| December 10, 2010 | K101433 | DEPUY ATTUNE KNEE SYSTEM | OIY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 23, 2010 | K102080 | DEPUY RECLAIM REVISION HIP SYSTEM | LZO | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| September 29, 2010 | K100391 | DEPUY UNIVERSAL GRIPTION TF CONES | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 14, 2009 | K091751 | DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP | KWS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 4, 2008 | K082585 | DEPUY ASPHERE M-SPEC HEAD | KWA | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 18, 2008 | K082500 | DEPUY SIGMA CR-F FEMORAL COMPONENT | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 30, 2008 | K081620 | MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM | KWS | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 14, 2008 | K081163 | SMARTSET GMV GENTAMICIN BONE CEMENT | MBB | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 14, 2008 | K081155 | SMARTSET MV BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 29, 2008 | K073676 | DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP | PHX | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 24, 2008 | K073529 | DEPUY SIGMA PS FEMORAL COMPONENTS | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 28, 2007 | K071830 | DEPUY DELTA TS CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 11, 2007 | K071379 | DELTA XTEND REVERSE SHOULDER MODULAR STEM | PHX | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 2, 2007 | K071417 | DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES | MBH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 2, 2007 | K062250 | DELTA XTEND REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 30, 2006 | K062748 | MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 28, 2006 | K061221 | DUPUY S-ROM STD HIP STEM PROSTHESIS | KWA | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 18, 2006 | K062116 | DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS | PHX | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 8, 2006 | K061144 | DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT | MBB | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 31, 2006 | K060031 | DEPUY MODULAR M HEADS | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 6, 2006 | K053445 | SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 22, 2005 | K053003 | DEPUY CMW 1, 2 AND 3 BONE CEMENTS | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 22, 2005 | K053002 | DEPUY CMW 1 GENTAMICIN BONE CEMENT | MBB | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 16, 2005 | K050315 | DELTA HUMERAL CUPS | PHX | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 1, 2004 | K041656 | MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 6, 2004 | K033273 | DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| April 8, 2004 | K040644 | MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 23, 2004 | K040166 | DEPUY SIGMA XLK TIBIAL INSERTS | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 5, 2004 | K033563 | SMARTSET GHV GENTAMICIN BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 5, 2004 | K033382 | SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 5, 2004 | K033272 | DEPUY SIGMA TIBIAL INSERTS | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 18, 2003 | K021478 | DELTA SHOULDER | PHX | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| September 29, 2003 | K023103 | DEPUY 1 GENTAMICIN BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 26, 2003 | K032151 | DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS | JWH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| July 1, 2003 | K031803 | DEPUY CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 13, 2003 | K023012 | SMARTSET HV BONE CEMENT | LOD | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 28, 2002 | K011533 | DEPUY FEMORAL HEADS | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| April 6, 2001 | K010171 | DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 12, 2000 | K001534 | PINNACLE ACETABULAR SYSTEM | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 23, 2000 | K000306 | PINNACLE ACETABULAR SYSTEM | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 27, 1998 | K983014 | SUMMIT ACETABULAR SYSTEM | LPH | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| May 29, 1998 | K980801 | J-FX BIPOLAR HEAD | KWY | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| April 14, 1998 | K980513 | ARTICUL/EZE FEMORAL HEADS | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 17, 1997 | K971189 | P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) | JWH | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| August 13, 1996 | K961939 | S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115) | LPH | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| July 10, 1996 | K961685 | P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) | JWH | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| February 26, 1996 | K955511 | ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP | LPH | Substantially Equivalent | Joint Medical Products Corp. | accessdata.fda.gov |
| January 31, 1996 | K953202 | P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT | JDI | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| January 31, 1996 | K953200 | ULTIMA SIZE 0 CEMENTED FEMORAL STEM | JDI | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| January 22, 1996 | K954935 | S-ROM FEMORAL HIP STEM - SIZE 14 X 8 | LPH | Substantially Equivalent | Joint Medical Products Corp. | accessdata.fda.gov |
| September 26, 1995 | K944538 | GAS PLASMA STERILIZATION | HRY | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| May 15, 1995 | K950010 | DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED | JWH | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| December 21, 1994 | K943462 | DARWIN KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| June 3, 1994 | K934412 | COATED ZT PROXIMAL SLEEVE | LPH | Substantially Equivalent | Joint Medical Products Corp. | accessdata.fda.gov |
| February 12, 1993 | K924379 | ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM | KWL | Substantially Equivalent | Johnson & Johnson Orthopaedics, Inc. | accessdata.fda.gov |
| April 1, 1992 | K910664 | MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN. | LWJ | Substantially Equivalent | Medimix Products, Inc. | accessdata.fda.gov |
| December 30, 1991 | K912713 | S-ROM ZT HA PROXIMAL FEMORAL SLEEVE | MEH | Substantially Equivalent for Some Indications | Joint Medical Products Corp. | accessdata.fda.gov |
| December 20, 1991 | K913231 | S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD | JDI | Substantially Equivalent | Joint Medical Products Corp. | accessdata.fda.gov |
| May 4, 1990 | K900832 | MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA. | JDI | Substantially Equivalent for Some Indications | Depuy, Inc. | accessdata.fda.gov |
| September 11, 1989 | K893872 | P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT | KWY | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| June 9, 1989 | K891083 | CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER | LZO | Substantially Equivalent for Some Indications | Depuy, Inc. | accessdata.fda.gov |
| March 29, 1989 | K884796 | P.F.C.(TM) MODULAR KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| September 18, 1985 | K851422 | S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP | JDI | Substantially Equivalent | Joint Medical Products Corp. | accessdata.fda.gov |
| November 15, 1984 | K843909 | TITANIUM HIP 1019 | JDI | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| May 2, 1980 | K800894 | DUPUY CEMENT RESTRICTOR TRIALS & INSTR. | JDI | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 23, 2010 | P070026 | CERAMAX CERAMIC HIP SYSTEM | MRA | 121 | September 4, 2026 | accessdata.fda.gov |
| February 11, 1997 | P960001 | DEPUY 1 BONE CEMENT | LOD | 8 | September 20, 1999 | accessdata.fda.gov |
| April 12, 1985 | P830055 | LCS(R) TOTAL KNEE SYSTEM | NJL | 355 | October 9, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 19, 2026 | 99078 | Class II | Ongoing | Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYSTEM REVISION HINGE HOUSING COMPONENT AND CROSSPIN B; Part Number: 151730010. 2. ATT | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | accessdata.fda.gov |
| April 3, 2026 | 98707 | Class II | Ongoing | Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104. | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | accessdata.fda.gov |
Compare with other makers
- All makers of Bone Cement
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Instruments Designed For Press-Fit Osteochondral Implants
- All makers of Tap, Bone
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Updated September 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.