BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    DEPUY INTL., LTD.

    Reg #: 8010379 · FEI: 1000199976 · Expires 2026
    View on FDA
    Products
    74
    Proprietary Names
    314
    Establishment Types
    3
    Classifications
    74

    Registration Details

    Registration Name
    DEPUY INTL., LTD.
    Registration Number
    8010379
    FEI Number
    1000199976
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ST. ANTHONYS RD.
    City
    LEEDS
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K013350
    PMA Number
    P960054

    Owner / Operator

    Firm Name
    DePuy Synthes, Inc.
    Operator Number
    1818910
    Address
    700 Orthopaedic Drive
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US

    US Agent

    Business Name
    DePuy Synthes
    Contact Name
    Patrick McCullagh
    Address
    700 Orthopaedic Drive
    City
    Warsaw
    State
    IN
    ZIP
    46582
    Country
    US
    Email
    [email protected]
    Phone
    267 3005417

    Products

    Device Name Product Code
    Hammer, Surgical FZY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Osteotome HWM
    Retractor GAD
    Impactor HWA
    Hook, Bone KIK
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained JWJ
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Elevator, Surgical, General & Plastic Surgery GEG
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Cement Obturator LZN
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Reamer HTO
    Passer, Wire, Orthopedic HXI
    Screwdriver HXX
    Goniometer, Nonpowered KQW
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Saw, Powered, And Accessories HAB
    Saw HSO
    Tray, Surgical, Instrument FSM
    Rasp HTR
    Bone Mill LYS
    Tamp HXG
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Caliper KTZ
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Skid, Bone HWO
    Neurological Stereotaxic Instrument HAW
    Bit, Drill HTW
    Evacuator, Vapor, Cement Monomer JDY
    Curette HTF
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Probe HXB
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Instrument, Manual, Surgical, General Use MDM
    Broach HTQ
    Scissors, General, Surgical LRW
    Knife, Orthopedic HTS
    Guide, Surgical, Instrument FZX
    Pusher, Socket HXO
    Punch, Surgical LRY
    File HTP
    Tap, Bone HWX
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing NJL
    Extractor HWB
    Gauge, Depth HTJ
    Wire, Surgical LRN
    Cutter, Wire HXZ
    Instrument, Cutting, Orthopedic HTZ
    Instrument, Compression HWN
    Clamp HXD
    Screw, Fixation, Bone HWC
    Rongeur HTX
    Scissors, Orthopedic, Surgical HRR
    Forceps, Wire Holding HYA
    Driver, Prosthesis HWR
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Motor, Surgical Instrument, Ac-Powered GEY
    Chisel (Osteotome) KDG
    Template HWT
    Instruments Designed For Press-Fit Osteochondral Implants QBO
    Orthopedic Manual Surgical Instrument LXH
    Table And Attachments, Operating-Room BWN
    Forceps, General & Plastic Surgery GEN

    Proprietary Names

    Joint Recon Hammers VARIOUS TYPES OF HAMMERS C-Stem (Hip) various osteotome general instruments TELIGEN PFC (knee) Instrument Retractors Impactor Instruments (Joint Recon) Bengal Expedium Viper Concorde Joint Recon Bone Hook Instrument Joint Recon Surgical instrument motors and accessories/attachments S-Rom (hip) Pinnacle (hip) Charnley Mitek ELEVATOR IFE Duraloc (hip), Solution, Sector, Profile, Bantam C-stem (hip) Enduron, Hylamer Change in pkg of UHMWPE components for Multicup, Ogee, cement restrictor, AMK poly tib & patella & tib insert, Synatomic Orthopaedic REAMER ATTUNE REVISION RP CONICAL REAMER Joint Recon Passer Wire Duraloc (hip) Focus (hip), Articul/eze Screwdrivers for Joint Recon Viper Prime joint recon Goniometers, nonpowered Articul/eze (hip) Corail (hip) AML, Duraloc (hip) PINNACLE Dual Mobility SAW FOOTSWITCH General Accessories WILLIAMS MICROSURGERY SAW POWER CONSOLE BLADE Triflange (hip) saw Vision (hip) AML instrument tray, instrument case ATTUNE REVISION SOLID RP INSERTS SIZE 5-6 CASE ATTUNE REVISION SOLID RP INSERTS SIZE 3-4 CASE ATTUNE REVISION TIBIAL BROACH CADDY ATTUNE REVISION SOLID RP INSERTS SIZE 7-8 CASE Rasp for Joint Recon RASP Lere Joint Ortho Tamp Instrument Ortron (hip), Charnley Attune (knee) Caliper Instruments (Joint Recon) Cathcart (hip), Articul/eze bone skid instrument CAS Orthopaedic DRILL EVACUATOR VAPOR CEMENT MONOMER (MULTIPLE BRANDS) VACU-MIX PUMP Joint Recon Curettes Global Unite (shoulder) Proxima Mitek PROBE chisel, instrument guide, hammer, mallet, osteotome, rasp, retractor, saw, calipers various broach instruments ATTUNE REVISION TIBIAL BROACH 45MM ATTUNE REVISION TIBIAL BROACH 61MM ATTUNE REVISION TIBIAL BROACH 37MM ATTUNE REVISION TIBIAL BROACH 29MM ATTUNE REVISION TIBIAL BROACH 53MM ATTUNE REVISION TIBIAL BROACH 69MM scissors Surgical Scissors S-ROM Mountaineer orthopaedic knife Mitek KNIFE Orthopaedic GUIDE Guide, Surgical, Instrument PFC Knee PUSHER SOCKET Bone Punch, Tibial Punch, Femoral Punch, Acetabular Punch Punch, Surgical Pinnacle AltrX Elite (hip) Duraloc (hip), Marathon Instrument file for Joint Recon Corail AMT (hip) Orthopaedic TAP ATTUNE Revision Tibial Base Rotating Platform Size 10 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 6 18 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 18MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 53 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 18 mm ATTUNE REVISION RP INSERT TRIAL SIZE 7 18MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 24MM ATTUNE Revision CRS Rotating Platform Insert Size 3 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 14 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 26 mm ATTUNE REVISION RP BASE TRIAL SIZE 4 ATTUNE REVISION RP INSERT TRIAL SIZE 4 12MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 45 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 16 mm ATTUNE REVISION RP INSERT TRIAL SIZE 7 16MM ATTUNE Revision CRS Rotating Platform Insert Size 4 10 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 16 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 61MM ATTUNE REVISION RP INSERT TRIAL SIZE 4 8MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 14MM ATTUNE Revision CRS Rotating Platform Insert Size 6 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 12 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 12MM ATTUNE Revision Tibial Base Rotating Platform Size 2 Cemented ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 61 mm ATTUNE Revision CRS Rotating Platform Insert Size 3 18 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 14 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 16MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 14MM ATTUNE Revision CRS Rotating Platform Insert Size 3 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 24 mm ATTUNE REVISION RP BASE TRIAL SIZE 3 ATTUNE REVISION RP INSERT TRIAL SIZE 4 10MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 24MM ATTUNE Revision CRS Rotating Platform Insert Size 3 12 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 18 mm ATTUNE REVISION RP BASE TRIAL SIZE 6 ATTUNE REVISION RP INSERT TRIAL SIZE 4 16MM ATTUNE Revision CRS Rotating Platform Insert Size 5 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 10 mm ATTUNE REVISION RP INSERT TRIAL SIZE 5 26MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 10MM ATTUNE Revision CRS Rotating Platform Insert Size 5 22 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 8MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 6MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 45 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 10 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 12MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 26MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 10MM ATTUNE Revision CRS Rotating Platform Insert Size 4 22 mm ATTUNE REVISION RP BASE TRIAL SIZE 8 ATTUNE REVISION RP INSERT TRIAL SIZE 4 20MM ATTUNE Revision CRS Rotating Platform Insert Size 5 20 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 18MM ATTUNE Revision CRS Rotating Platform Insert Size 4 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 10 mm ATTUNE REVISION RP BASE TRIAL SIZE 10 ATTUNE REVISION RP INSERT TRIAL SIZE 4 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 10MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 29 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 22 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 6 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 22MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 6MM ATTUNE Revision CRS Rotating Platform Insert Size 4 12 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 18 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 69MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 16MM ATTUNE Revision Tibial Base Rotating Platform Size 9 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 5 10 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 16 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 16MM ATTUNE Revision CRS Rotating Platform Insert Size 5 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 14 mm ATTUNE REVISION RP INSERT TRIAL SIZE 5 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 14MM ATTUNE Revision Tibial Sleeve 29 mm Cemented ATTUNE Revision CRS Rotating Platform Insert Size 6 20 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 26MM ATTUNE Revision CRS Rotating Platform Insert Size 4 24 mm ATTUNE REVISION RP BASE TRIAL SIZE 9 ATTUNE REVISION RP INSERT TRIAL SIZE 4 22MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 8MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 37 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 24 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 8 mm ATTUNE REVISION RP INSERT TRIAL SIZE 6 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 8MM ATTUNE Revision Tibial Base Rotating Platform Size 3 Cemented ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 69 mm ATTUNE Revision CRS Rotating Platform Insert Size 3 20 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 16 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 18MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 16MM ATTUNE Revision CRS Rotating Platform Insert Size 5 24 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 8 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 10MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 7 8MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 37 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 14 mm ATTUNE REVISION RP INSERT TRIAL SIZE 7 14MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 69 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 22 mm ATTUNE REVISION RP BASE TRIAL SIZE 2 ATTUNE REVISION RP INSERT TRIAL SIZE 7 22MM ATTUNE Revision CRS Rotating Platform Insert Size 5 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 6 12 mm ATTUNE REVISION RP INSERT TRIAL SIZE 4 26MM ATTUNE REVISION RP INSERT TRIAL SIZE 6 12MM ATTUNE Revision Tibial Base Rotating Platform Size 6 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 3 26 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 22 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 37MM ATTUNE REVISION RP INSERT TRIAL SIZE 3 24MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 8MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 22MM ATTUNE Revision Tibial Base Rotating Platform Size 5 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 3 24 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 20 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 29MM ATTUNE REVISION RP INSERT TRIAL SIZE 3 22MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 20MM ATTUNE Revision Tibial Base Rotating Platform Size 4 Cemented ATTUNE Revision Tibial Base Rotating Platform Size 7 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 4 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 12 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 24 mm ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 29 mm ATTUNE Revision CRS Rotating Platform Insert Size 3 22 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 45MM ATTUNE REVISION RP INSERT TRIAL SIZE 3 26MM ATTUNE Revision CRS Rotating Platform Insert Size 8 18 mm ATTUNE REVISION RP INSERT TRIAL SIZE 5 10MM ATTUNE REVISION RP STEM ADAPTOR TRIAL ATTUNE REVISION RP INSERT TRIAL SIZE 3 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 18MM ATTUNE Revision CRS Rotating Platform Insert Size 3 14 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 20 mm ATTUNE REVISION RP BASE TRIAL SIZE 7 ATTUNE REVISION RP INSERT TRIAL SIZE 4 18MM ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 61 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 20 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 26 mm ATTUNE REVISION RP INSERT TRIAL SIZE 7 20MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 26MM ATTUNE Revision CRS Rotating Platform Insert Size 3 10 mm ATTUNE Revision CRS Rotating Platform Insert Size 4 16 mm ATTUNE REVISION RP BASE TRIAL SIZE 5 ATTUNE REVISION RP INSERT TRIAL SIZE 4 14MM ATTUNE Revision Tibial Base Rotating Platform Size 8 Cemented ATTUNE Revision CRS Rotating Platform Insert Size 4 8 mm ATTUNE Revision CRS Rotating Platform Insert Size 5 14 mm ATTUNE REVISION TIBIAL SLEEVE TRIAL 53MM ATTUNE REVISION RP INSERT TRIAL SIZE 4 6MM ATTUNE REVISION RP INSERT TRIAL SIZE 5 12MM ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 53 mm ATTUNE Revision CRS Rotating Platform Insert Size 3 16 mm ATTUNE Revision CRS Rotating Platform Insert Size 7 6 mm ATTUNE Revision CRS Rotating Platform Insert Size 8 12 mm ATTUNE REVISION RP INSERT TRIAL SIZE 3 14MM ATTUNE REVISION RP INSERT TRIAL SIZE 8 12MM TRUMATCH Personalized Solutions ATTUNE® Revision Knee System LCS, New Jersey Total Knee C-Stem AMT (hip), Articul/eze Orthopaedic EXTRACTOR ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - ATTUNE SLEEVE WEDGE ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - BASE ATTACHMENT ATTUNE REVISION TIBIAL BASE TRIAL EXTRACTOR ATTUNE REVISION BOSS AND STEM ADAPTOR TRIAL EXTRACTOR WILLIAMS GAUGES Wire Cable (joints) C-Stem (hip), Articul/eze Hip Ball Joint Reconstruction wire cutters Joint Recon Cutting Instrument compression instrument for Joint Recon ARICULATED TENSION DEVICE SYNTHES TEN Clamp for Joint Recon C-Stem (hip) Rongeur for Joint Recon Scissors, orthopedic, surgical Joing Recon Forceps, Wire Holding Marathon (hip), Duraloc S-Rom (hip), Articul/eze, M-Spec various prosthesis drivers ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - DRIVER PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED PFC (hip) ASphere (hip), M-Spec surgical instrument motor power Corail Stem, AMT (hip) CHISEL (OSTEOTOME) templates guides broach, wire cutter, prosthesis driver, extractor, file, femoral neck punch, reamer, screwdriver, tamp wrench, etc. Attune Pinnacle ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 5 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 4 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 8 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 3 ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 7 ATTUNE REVISION FEMORAL IM ADAPTOR ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 6 HPS (hip) OR table attachments Acclaim Global Advantage M-Spec (Hip)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Sterilize Medical Device for Another Party (Contract Sterilizer)