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510(k) Data Aggregation

    K Number
    K180821
    Device Name
    TruMatch Graft Cage - Long Bone
    Manufacturer
    Synthes (USA) LLC
    Date Cleared
    2018-12-21

    (266 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Synthes (USA) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DePuy Synthes TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally mature adults and adolescents (12-21)* for maintaining the relative position of bone grafts and/or bone graft substitutes within bone voids or surgical resections in the nonarticular regions of the humerus, femur, or tibia. The implant must be used in conjunction with traditional, rigid fixation. *The TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally immature adolescents, only if the device is not used across open physes. The TruMatch Graft Cage – Long Bone implant is for patients only when the treating physician deems there is appropriate time to conduct surgical planning, personalization, and manufacturing of a patient specific device. When considering the use of the TruMatch Graft Cage - Long Bone, please ensure that you request information on the amount of time needed to manufacture and ship the device from your local DePuy Synthes sales representative. There is a delay between when the device is ordered and when the device can be delivered.
    Device Description
    DePuy Synthes TruMatch Graft Cage - Long Bone, is a 3D-printed personalized resorbable implant that optimizes support of bone graft in large, segmental defects of the humerus, femur, and tibia.
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    K Number
    K130146
    Device Name
    SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
    Manufacturer
    SYNTHES (USA) LLC
    Date Cleared
    2013-05-20

    (118 days)

    Product Code
    NDN, HRX
    Regulation Number
    888.3027
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTHES (USA) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synflate Vertebral Balloon System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
    Device Description
    The Synflate Vertebral Balloon System is a comprehensive array of instrumentation (Vertebral Access Kit as well as a Biopsy Kit), vertebral augmentation balloons (inclusive of balloon-catheter, stiffening wire, and syringe with luer lock), and Inflation System (previously cleared via K110604). All instruments and implants are provided sterile and packaged separately. The Synflate balloon catheter includes a stiffening wire and syringe with luer lock. The balloon is inflated within the vertebral body via the Inflation System. The Synflate balloon catheter is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
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    K Number
    K120275
    Device Name
    SYNTHES ACIS/VERTEBRAL SPACER CR
    Manufacturer
    SYNTHES (USA) LLC
    Date Cleared
    2012-05-25

    (116 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTHES (USA) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synthes ACIS is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer of the Synthes ACIS should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes ACIS is intended to be used with supplemental fixation. The Synthes Vertebral Spacer CR is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the Synthes Vertebral Spacer CR should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes Vertebral Spacer CR is intended to be used with supplemental fixation.
    Device Description
    The Synthes ACIS is a radiolucent cervical intervertebral body fusion device. The Synthes ACIS is fabricated from Invibio® PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and one posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant. The Synthes Vertebral Spacer CR is a radiolucent cervical intervertebral body fusion device. The Vertebral Spacer CR is fabricated from Invibio® PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and one posterior titanium alloy (Titanium-6Aluminum-7Niobium ASTM F1295-05) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant. The Synthes Vertebral Spacer CR is available in a range of heights, and is available in three different sagittal profiles. Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. The open architecture of the device allows it to be packed with autogenous bone graft material, i.e., autograft.
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    K Number
    K101536
    Device Name
    2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM
    Manufacturer
    SYNTHES (USA) LLC
    Date Cleared
    2010-09-15

    (104 days)

    Product Code
    HRS, HWC
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNTHES (USA) LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Synthes 2.7 mm/ 3.5 mm VA-LCP Anterior Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
    Device Description
    The Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System consists of plates of various lengths and variable angle screws that provide the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole. The system features medial and lateral plates that are precontoured to match the anatomy of the clavicle and a limited contact, low profile design. The plate with lateral extension features Variable Angle (VA) Locking holes and Dynamic Compression Plate (DCP) holes. The medial plate features Dynamic Compression Plate (DCP) holes combined with VA locking screw holes.
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