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510(k) Data Aggregation

    K Number
    K191192
    Device Name
    SurgTech GENOLL Total Knee System
    Manufacturer
    Date Cleared
    2019-08-01

    (90 days)

    Product Code
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SurgTech, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Surg Tech GENOLL™ system is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is intended for cemented use only.
    Device Description
    The SurgTech GENOLL"Total Knee System is used for total knee arthroplasty in skeletally mature individuals. The system consists of a CoCr alloy Posterior Stabilized (PS) femoral component (10 sizes, Left and Right), a CoCr alloy tibial baseplate (10 sizes), a conventional polyethylene PS tibial bearing insert (5 sizes with 5 thicknesses each) and a conventional polyethylene patella (3 sizes). Instrumentation necessary for proper implantation is also included.
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    K Number
    K173455
    Device Name
    SurgTech Bipolar Head System
    Manufacturer
    Date Cleared
    2018-06-14

    (219 days)

    Product Code
    Regulation Number
    888.3390
    Why did this record match?
    Applicant Name (Manufacturer) :

    SurgTech, Inc.,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SurgTech Bipolar Head system is intended for use for cases of: • Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia. - · Inflammatory degenerative joint disease such as rheumatoid arthritis. - Correction of function deformity. - · Revision procedures where other treatments or devices have failed. · Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
    Device Description
    The SurgTech Bipolar Head System is used for hip hemiarthroplasty in skeletally mature individuals. The system consists of a CoCr alloy shell (38-58mm outer diameters), a polyethylene bearing insert (22mm and 28mm inner diameters) and retaining ring, and CoCr alloy femoral heads (22mm and 28mm) in various offsets. Instrumentation necessary for proper implantation is also included.
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    K Number
    K162125
    Device Name
    MALUC™ Total Hip Arthroplasty System
    Manufacturer
    Date Cleared
    2017-05-10

    (282 days)

    Product Code
    Regulation Number
    888.3350
    Why did this record match?
    Applicant Name (Manufacturer) :

    SurgTech, Inc.,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SurgTech MALUC™ System is intended for use for cases of severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head or neck, failed previous hip surgery (including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty and/or total arthroplasty), and certain cases of ankylosis.
    Device Description
    The MALUC™ Total Hip Arthroplasty System is used for primary total hip replacement in skeletally mature individuals. The system consists of monolithic cemented and press-fit femoral stems, modular CoCr and BIOLOX® delta femoral heads in various sizes and offsets, uncemented acetabular shells and conventional polyethylene liners. Accessory components include distal centralizers, cancellous bone screws and cement restrictors. Instrumentation necessary for proper implantation is also included.
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