Data / Medical devices / United Kingdom / Depuy Intl., Ltd.
Depuy Intl., Ltd.: FDA-registered device maker in Leeds, United Kingdom, 59 510(k) clearances and 2 PMA approvals
Depuy Intl., Ltd. is registered with the FDA (registration 8010379) in Leeds, United Kingdom. It lists 76 device types. The FDA files 59 510(k) clearances and 2 PMA approvals under its listings, the newest dated May 15, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8010379
- FEI number
- 1000199976
- Address
- ST. Anthonys RD., Leeds, United Kingdom, LS11 8DT
- Owner or operator
- DePuy Synthes, Inc. (1818910)
- Roles
- Contract sterilizer, Manufacturer, Specification developer
- First device listed
- December 22, 1977
- Registered through
- 2027
- Brand names listed
- AML, Duraloc (hip), ARICULATED TENSION DEVICE SYNTHES TEN, ASphere (hip), M-Spec, 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 |
|---|---|---|---|---|---|---|
| May 15, 2026 | K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | KWL | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| May 23, 2025 | K251292 | RECLAIM Monobloc Revision Femoral Stem | LZO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| April 4, 2024 | K240639 | PINNACLETM Constrained Acetabular Liners | KWZ | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| 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 |
| December 19, 2023 | K231526 | CORAIL Cemented Femoral Stem | KWY | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| January 6, 2023 | K222296 | ARTICUL/EZE Ceramic Heads | LZO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| October 21, 2022 | K221462 | DePuy Reclaim Monobloc Revision Femoral Stem | LZO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| July 22, 2022 | K220216 | C-Stem AMT LE Prosthesis | JDI | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| April 28, 2021 | K203532 | BI-MENTUM ALTRX® Dual Mobility Liner | LZO | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| September 11, 2020 | K200854 | DePuy PINNACLE Dual Mobility Liner | LPH | Substantially Equivalent | Depuy Ireland UC | 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 30, 2013 | K120599 | DEPUY M-SPEC 36MM FEMORAL HEADS | LPH | Substantially Equivalent | Depuy Orthopaedics | accessdata.fda.gov |
| March 10, 2011 | K093736 | DEPUY CORAIL HIP SYSTEM, REVISION STEM | LZO | 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 |
| October 29, 2010 | K102423 | DEPUY PINNACLE ALTRX ACETABULAR LINERS | LPH | 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 |
| August 29, 2008 | K082239 | DEPUY C-STEM AMT | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 9, 2008 | K072963 | DEPUY PINNACLE ALTRX ACETABULAR LINERS | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 11, 2007 | K070554 | DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 24, 2006 | K062148 | DEPUY PINNACLE ALTRX ACETABULAR CUP LINER | LPH | 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 |
| March 4, 2005 | K043223 | DEPUY CAS KNEE INSTRUMENTATION | HAW | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 11, 2005 | K042992 | CORAIL AMT HIP PROSTHESIS | LZO | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 22, 2004 | K042959 | DEPUY C-STEM AMT HIP PROSTHESIS | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 28, 2004 | K040544 | DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 | LPH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| May 12, 2004 | K040383 | TRIFLANGE II ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 7, 2001 | K013350 | MODIFICATION TO DEPUY C-STEM SYSTEM | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 1, 2000 | K003421 | DEPUY C-STEM SYSTEM | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 23, 2000 | K001277 | TRIFLANGE ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| February 3, 2000 | K994415 | MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 5, 1998 | K982918 | DEPUY C-STEM SYSTEM | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| April 14, 1998 | K980513 | ARTICUL/EZE FEMORAL HEADS | JDI | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| November 12, 1997 | K972596 | DEPUY DURALOC ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| June 27, 1997 | K971682 | J-FX CERCLAGE SYSTEM | LRN | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| September 17, 1996 | K961186 | DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| February 1, 1996 | K953694 | DEPUY VISION AML HIP PROTHESIS | LPH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| September 18, 1995 | K940743 | UHMWPE COMPONENTS-CHANGE IN PACKAGING | KWY | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| August 18, 1995 | K952740 | DEPUY DURALOC 400 ACETABULAR CUP | LPH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| February 9, 1994 | K931189 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET | LZO | Substantially Equivalent | Johnson & Johnson Orthopaedics, Inc. | accessdata.fda.gov |
| October 4, 1993 | K930712 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR | LZO | Substantially Equivalent | Johnson & Johnson Orthopaedics, Inc. | accessdata.fda.gov |
| November 24, 1992 | K924492 | POLY-DIAL INSERTS | LPH | Substantially Equivalent for Some Indications | Joint Medical Products Corp. | accessdata.fda.gov |
| March 19, 1992 | K920317 | S-ROM LF FEMORAL HEAD | JDI | Substantially Equivalent | Joint Medical Products Corp. | accessdata.fda.gov |
| October 3, 1990 | K903084 | MODULAR CATHCART FRACTURE SYSTEM | LZY | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| August 24, 1990 | K902395 | MODIFIED AML + ACETABULAR CUP SYSTEM | JDI | Substantially Equivalent for Some Indications | Depuy, Inc. | accessdata.fda.gov |
| June 26, 1990 | K902137 | P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT | JDI | Substantially Equivalent | Johnson & Johnson Orthopaedics, Inc. | 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 |
| March 29, 1989 | K884796 | P.F.C.(TM) MODULAR KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| October 20, 1988 | K882234 | JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS | JWH | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| October 11, 1988 | K883460 | FOCUS TOTAL HIP SYSTEM | JDI | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| April 8, 1988 | K871867 | ELITE MODULAR HIP SYSTEM | JDI | Substantially Equivalent | Thackray USA | accessdata.fda.gov |
| October 28, 1987 | K873585 | POROUS COATED ACETABULAR CUP | JDI | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| April 20, 1987 | K870271 | S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP | KWZ | Substantially Equivalent for Some Indications | Joint Medical Products Corp. | accessdata.fda.gov |
| March 19, 1986 | K860701 | HPS II SMOOTH STEM | JDI | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| September 19, 1985 | K853655 | NEW JERSEY MODULAR FEMORAL HIP | JDI | Substantially Equivalent for Some Indications | Depuy, 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 |
| June 4, 1985 | K851421 | S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP | LPH | Substantially Equivalent | Joint Medical Products Corp. | accessdata.fda.gov |
| November 15, 1984 | K843909 | TITANIUM HIP 1019 | JDI | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| December 16, 1980 | K802627 | ORTRON 90* HIP PROSTHESIS | JDI | Substantially Equivalent | Cintor Orthopaedic Div. | 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 |
|---|---|---|---|---|---|---|
| June 19, 1997 | P960054 | S-ROM POLY-DIAL CONSTRAINED LINER | KWZ | 3 | December 22, 1999 | accessdata.fda.gov |
| April 12, 1985 | P830055 | LCS(R) TOTAL KNEE SYSTEM | NJL | 355 | October 9, 2026 | accessdata.fda.gov |
Compare with other makers
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- All makers of Driver, Prosthesis
Updated May 15, 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.