BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DEPUY ORTHOPAEDICS, INC.

    Reg #: 1219655 · FEI: 1219655 · Expires 2026
    View on FDA
    Products
    76
    Proprietary Names
    317
    Establishment Types
    3
    Classifications
    76

    Registration Details

    Registration Name
    DEPUY ORTHOPAEDICS, INC.
    Registration Number
    1219655
    FEI Number
    1219655
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    325 PARAMOUNT DR.
    City
    RAYNHAM
    State
    MA
    ZIP
    02767
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182670
    PMA Number
    P830055

    Owner / Operator

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

    Products

    Device Name Product Code
    Goniometer, Nonpowered KQW
    Osteotome HWM
    Hammer, Surgical FZY
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing NJL
    Filler, Bone Void, Calcium Compound MQV
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Rongeur HTX
    Syringe, Piston FMF
    Driver, Prosthesis HWR
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Knee Arthroplasty Implantation System OOG
    Gouge, Surgical, General & Plastic Surgery GDH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Tap, Bone HWX
    Neurological Stereotaxic Instrument HAW
    Pusher, Socket HXO
    Chisel, Surgical, Manual FZO
    Mesh, Surgical, Acetabular, Hip, Prosthesis JDJ
    Wrench HXC
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Hook, Bone KIK
    Instrument, Compression HWN
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Bit, Drill HTW
    Screwdriver HXX
    Mallet, Surgical, General & Plastic Surgery GFJ
    Passer, Wire, Orthopedic HXI
    Caliper KTZ
    Tape, Measuring, Rulers And Calipers FTY
    Guide, Surgical, Instrument FZX
    Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
    Retractor GAD
    Saw HSO
    Clamp HXD
    Impactor HWA
    Broach HTQ
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Wire, Surgical LRN
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Screw, Fixation, Bone HWC
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Instrument, Manual, Surgical, General Use MDM
    Curette HTF
    Burr, Orthopedic HTT
    File HTP
    Extractor HWB
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Cutter, Wire HXZ
    Awl HWJ
    Tamp HXG
    Pliers, Surgical HTC
    Template HWT
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Orthopedic Manual Surgical Instrument LXH
    Forceps, General & Plastic Surgery GEN
    Gauge, Depth HTJ
    Instrument, Cutting, Orthopedic HTZ
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Rasp HTR
    Tray, Surgical, Instrument FSM
    Forceps, Wire Holding HYA
    Reamer HTO

    Proprietary Names

    joint recon Goniometers, nonpowered various osteotome general instruments TELIGEN Joint Recon Hammers VARIOUS TYPES OF HAMMERS 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 Accessories/Attachmnts to AC Powered Motors for Joint Recon LPS, Orthogenesis Rongeur for Joint Recon Expedium various prosthesis drivers ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - DRIVER TruMatch (instruments) Gouge instrumnts for Joint Recon Sterilization change for: AMK (knee), AML (hip), Preservation (knee), Enduron (hip), Hylamer (knee), Duraloc (hip), Bantam (hip), Endurance (hip), ERS (elbow), Synatomic (knee), Global (shoulder), Self-Centering (hip), ACS (hip) Coordinate (knee) S-ROM Hip System Orthopaedic TAP CI (hip) PUSHER SOCKET Joint Recon instrument -chisel, surgical, manual spine instrument Sigma PS 150 Protrusio PFC Knee PFC (Knee) CAS PFC MODULAR PLUS OFFSET TIBIAL TRAY wrenches for Joint Recon ATTUNE REVISION FEMORAL STRAIGHT STEM WRENCH S-ROM NOILES PS TOTAL KNEE SYSTEM (ALL POLYETHYLENE) Joint Recon Surgical instrument motors and accessories/attachments PFC Sigma (knee), Darwin SOLUTION SYSTEM HIP PROSTHESIS PFC SIGMA KNEE SYSTEM DELTA XTEND Reverse Shoulder System Vision (hip) AML SIGMA KNEE PROSTHESIS PFC SIGMA POROUS MODULAR KEEL TIBIAL TRAY BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL blade Joint Recon Bone Hook Instrument LPS, Universal (knee) compression instrument for Joint Recon Viper Prime ARICULATED TENSION DEVICE SYNTHES TEN Sigma High Performance (Knee) LPS Metaphyseal Sleeve Sigma (knee) PFC Sigma (knee) ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP Orthopaedic DRILL Charnley AML Hip Screwdrivers for Joint Recon Joint Recon Mallet instruments Sigma, Bannister (knee) Joint Recon Passer Wire Caliper Instruments (Joint Recon) Bengal S-Rom, Noiles (knee) Darwin (knee), PFC Sigma tape, measuring, rulers and calipers for Joint Recon measuring Orthopaedic GUIDE Guide, Surgical, Instrument Solution System Hip Prosthesis S Rom (hip) Instrument Retractors saw Cement Restrictor Clamp for Joint Recon PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Impactor Instruments (Joint Recon) Viper Concorde S Rom, Noiles (knee) 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 PFC Modular Total Knee System AML Hip Prosthesis SIGMA® High Performance Partial Knee System chisel, instrument guide, hammer, mallet, osteotome, rasp, retractor, saw, calipers METAPHYSEAL SLEEVES (Knee- PFC, SIGMA, S-ROM, LPS, LPS) Attune (Knee) Bone Screw S-Rom (hip) Joint Recon Curettes Gription (hip) Noiles (knee) Burr, Orthopedic Microlock (knee), PFC Instrument file for Joint Recon ATTUNE All Polyethylene Tibia 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 PINNACLE Dual Mobility SIGMA HIGH PERFORMANCE PARTIAL KNEE SYSTEM [GCK] Joint Reconstruction wire cutters Hip Screw Joint Recon Awl instruments Joint Ortho Tamp Instrument Summit (hip) various general plier instruments Attune (knee) Sigma (knee), Bannister, Darwin 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 Acclaim Global Advantage WILLIAMS GAUGES Joint Recon Cutting Instrument Darwin (knee), TC3, PFC Sigma PFC Sigma Patella ATTUNE REV FB INSERT IMPACTOR Rasp for Joint Recon RASP CAS (hip) 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 Joing Recon Forceps, Wire Holding Orthopaedic REAMER ATTUNE REVISION RP CONICAL REAMER

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only