Data / Medical devices / United States / Depuy Orthopaedics, Inc.
Depuy Orthopaedics, Inc.: FDA-registered device maker in Raynham, MA, United States, 75 510(k) clearances and 1 PMA approval
Depuy Orthopaedics, Inc. is registered with the FDA (registration 1219655) in Raynham, MA, United States. It lists 76 device types. The FDA files 75 510(k) clearances and 1 PMA approval under its listings, the newest dated September 4, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1219655
- Address
- 325 Paramount DR., Raynham, MA, United States, 02767
- Owner or operator
- DePuy Synthes, Inc. (1818910)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 22, 1977
- Registered through
- 2027
- Brand names listed
- AML Hip, AML Hip Prosthesis, ARICULATED TENSION DEVICE SYNTHES TEN, ATTUNE All Polyethylene Tibia, 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 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 |
|---|---|---|---|---|---|---|
| September 4, 2026 | K262130 | ATTUNE Revision Knee System | JWH | Substantially Equivalent | Depuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 22, 2026 | K252887 | DePuy ATTUNE Knee System | OIY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 22, 2025 | K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| June 24, 2025 | K251648 | GPS Advanced; GPS Advanced Cannula | FMF | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| July 10, 2024 | K241426 | GPS Advanced; 5 cc GPS Advanced Cannula | FMF | Substantially Equivalent | Prosidyan, Inc. | 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 |
| October 15, 2022 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | ODP | Substantially Equivalent | Depuy Spine | accessdata.fda.gov |
| August 23, 2022 | K213803 | FIBERGRAFT Aeridyan Matrix Bone Graft Substitute | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| June 16, 2020 | K193540 | TRUMATCH Personalized Solutions | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| April 16, 2020 | K193549 | SIGMA High Performance (HP) Partial Knee System | HRY | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| February 24, 2020 | K192855 | DELTA XTEND(TM) Reverse Shoulder System | PHX | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| January 30, 2020 | K193057 | ATTUNE All-Polyethylene Tibia | JWH | Substantially Equivalent | Depuy Ireland UC | accessdata.fda.gov |
| October 8, 2019 | K191779 | Attune Revision LPS Inserts | KRO | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| December 20, 2018 | K182670 | FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| April 6, 2018 | K180080 | FIBERGRAFT BG Matrix Bone Graft Substitute | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| June 30, 2017 | K171284 | FIBERGRAFT BG Matrix Bone Graft Substitute | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| May 24, 2017 | K170306 | FIBERGRAFT BG Putty Bone Graft Substitute | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| June 10, 2016 | K160700 | ATTUNE Revision Knee System | JWH | Substantially Equivalent | Depuy(Ireland) | accessdata.fda.gov |
| March 25, 2015 | K143533 | FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | Prosidyan, Inc. | accessdata.fda.gov |
| March 1, 2013 | K123924 | DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS | LZO | Substantially Equivalent | Depuy Orthopaedics | accessdata.fda.gov |
| August 30, 2011 | K111433 | DEPUY STTUNE (TM) PS KNEE SYSTEM | OIY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 16, 2011 | K110397 | TRUMATCH PERSONALIZED SOLUTIONS | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| December 10, 2010 | K101433 | DEPUY ATTUNE KNEE SYSTEM | OIY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 12, 2009 | K091453 | LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 | KRO | 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 |
| August 17, 2007 | K070267 | DEPUY GCK TIBIAL COMPONENTS | HRY | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| June 26, 2007 | K070849 | DEPUY GCK FEMORAL AND TIBIAL COMPONENTS | NPJ | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 23, 2007 | K071135 | DEPUY CI HIP INSTRUMENTATION | HAW | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 2, 2007 | K063633 | DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 11, 2006 | K061648 | DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) | NPJ | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| July 17, 2006 | K061833 | DEPUY AML HIP PROSTHESIS | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| May 19, 2006 | K060581 | DEPUY SOLUTION SYSTEM HIP PROSTHESIS | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| March 23, 2006 | K060515 | DEPUY PFC SIGMA KNEE PROSTHESIS | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 21, 2005 | K052178 | DEPUY CAS HIP INSTRUMENTATION | HAW | 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 |
| July 9, 2004 | K040281 | LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM) | JWH | 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 | K033272 | DEPUY SIGMA TIBIAL INSERTS | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| April 24, 2003 | K030979 | MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| October 19, 2001 | K012364 | AML HIP PROSTHESIS | LPH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| September 7, 2001 | K011810 | ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING | KRO | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| June 9, 1999 | K991106 | P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY | JWH | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| January 28, 1999 | K984158 | P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY | JWH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| October 27, 1998 | K983014 | SUMMIT ACETABULAR SYSTEM | LPH | Substantially Equivalent | Johnson & Johnson Professionals, 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 |
| July 16, 1997 | K971652 | P.F.C. SIGMA INSET PATELLA | JWH | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| June 9, 1997 | K970929 | DEPUY LOW PROFILE BONE SCREW | HWC | Substantially Equivalent for Some Indications | Depuy, Inc. | accessdata.fda.gov |
| November 6, 1996 | K963117 | P.F.C. CRUCIATE RETAING KNEE SYSTEM | JWH | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| October 17, 1996 | K963206 | S-ROM HIP SYSTEM - LOCKING PLUG | JDI | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| October 10, 1996 | K954481 | P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM | HRY | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| August 1, 1996 | K962007 | PROTRUSION CAGES | JDJ | Substantially Equivalent | Depuy, 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 |
| March 13, 1996 | K955884 | COORDINATE REVISION KNEE SYSTEM | JWH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| February 1, 1996 | K953694 | DEPUY VISION AML HIP PROTHESIS | LPH | Substantially Equivalent | Depuy, Inc. | accessdata.fda.gov |
| January 18, 1996 | K952830 | DARWIN KNEE SYSTEM (TC3) | JWH | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | 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 |
| April 14, 1995 | K951000 | ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM | LPH | Substantially Equivalent | Joint Medical Products Corp. | accessdata.fda.gov |
| February 1, 1995 | K941769 | KNEE PROTHESIS | JWH | Substantially Equivalent for Some Indications | Joint Medical Products Corp. | accessdata.fda.gov |
| December 21, 1994 | K943462 | DARWIN KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| October 3, 1994 | K936037 | S-ROM NOILES CRUCIATE RETAINING KNEE | JWH | Substantially Equivalent for Some Indications | Joint Medical Products Corp. | accessdata.fda.gov |
| June 3, 1994 | K935262 | P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA | JWH | Substantially Equivalent for Some Indications | Johnson & Johnson Orthopaedics, Inc. | accessdata.fda.gov |
| May 18, 1994 | K931676 | S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG | JDL | Substantially Equivalent | Joint Medical Products Corp. | accessdata.fda.gov |
| March 9, 1993 | K924940 | FEMORAL & TIBIAL AUGMENT BLOCK | JWH | Substantially Equivalent for Some Indications | Joint Medical Products Corp. | accessdata.fda.gov |
| November 9, 1992 | K923807 | P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS | JWH | Substantially Equivalent | Johnson & Johnson International | accessdata.fda.gov |
| April 1, 1992 | K910664 | MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN. | LWJ | Substantially Equivalent | Medimix Products, Inc. | accessdata.fda.gov |
| March 14, 1990 | K896048 | S-ROM/NOILES MARK 3 | KRO | Substantially Equivalent | Joint Medical Products Corp. | 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 |
| June 10, 1988 | K882008 | ACE SCREW REMOVAL TREPHINE | HWE | Substantially Equivalent | Buckman Co., Inc. | accessdata.fda.gov |
| May 26, 1987 | K870730 | NOILES TOTAL KNEE PROSTHESIS | JWH | Substantially Equivalent | Joint Medical Products Corp. | 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 |
| January 15, 1987 | K861979 | AML II TITANIUM ACETABULUM PROSTHESIS | JDI | Substantially Equivalent for Some Indications | Depuy, Inc. | accessdata.fda.gov |
| July 19, 1983 | K830927 | KNEE PROSTHESIS-TIBIAL COMPONENT | JWH | Substantially Equivalent | Johnson & Johnson Professionals, 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 |
|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| July 26, 2017 | 79072 | Class II | Terminated | Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine. | Potential for Intra-operative breakage of driver tips | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- All makers of Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Elbow, Semi-Constrained, Cemented
- All makers of Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Updated October 9, 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.