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510(k) Data Aggregation

    K Number
    K050473
    Device Name
    RBK PATELLA FEMORAL KNEE
    Date Cleared
    2005-11-14

    (263 days)

    Product Code
    Regulation Number
    888.3540
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RBK Patella Femoral Knee is intended for use in treating patients with osteoarthritis in the distal femur and patella, patients with a history of patellar fracture and those patients with failed previous surgery where pain, deformity or dysfunction persists. The device is a singleuse implant that is intended for use with bone cement.
    Device Description
    The RBK Patella Femoral Knee System consists of femoral and patellar components. The femoral component is anatomic in design, to provide coverage of the condyles from posterior to anterior. The anatomic shape of the femoral component necessitates separate left and right geometries. A group of four pegs (posts) on the back of the femoral component assists in cement fixation and rotational stability. The device is manufactured from cobalt chrome alloy that conforms to ASTM F-75-01. The patella components are offered in one configuration; circular, domed, all UHMWPE. The polymer components are manufactured from compression molded ultra-high molecular weight polyethylene (UHMWPE) that conforms to ASTM F-648-00. The domed, all poly patella buttons are available in 5 diameters (24mm - 40mm).
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    K Number
    K051721
    Device Name
    GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
    Date Cleared
    2005-10-26

    (121 days)

    Product Code
    Regulation Number
    888.3530
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K033351
    Device Name
    GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE
    Date Cleared
    2004-03-11

    (143 days)

    Product Code
    Regulation Number
    888.3530
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Global Resurfacing Unicompartmental (GRU) Knee System is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial conclyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single-use implant that is intended for use with bone cement.
    Device Description
    The Global Resurfacing Unicompartmental Knee System consists of femoral and tibial components. The femoral component is anatomic in design, to provide coverage of the condyle from posterior to anterior. The anatomic shape of the femoral component necessitates separate left and right geometries. A central keel and post on the back of the femoral component assists in cement fixation and rotational stability. The device is manufactured from cobalt chrome alloy that conforms to ASTM F-75-01. The tibial component is semi-lunar in configuration and manufactured from compression molded ultra-high molecular weight polyethylene (UHMWPE) that conforms to ASTM F-648-00. The tibial component is universal in geometry.
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