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510(k) Data Aggregation

    K Number
    K132539
    Device Name
    RING-LOK MODULAR BIPOLAR SYSTEM
    Date Cleared
    2014-02-07

    (178 days)

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

    IMPLANTS INTERNATIONAL, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ring-Lok™ Modular Bi-Polar System is intended for use in combination with other previously cleared femoral components including the Rig-Fix™ Hip Stem (K072101), C-fit Performa (K923898) or the Stability Hip Stem (K915787 and K934457) for uncemented primary or revision hemi-arthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: - Femoral neck and trochanteric fractures of the proximal femur . - Osteonecrosis of the femoral head . - Revision procedures where other treatments or devices or these indications have failed.
    Device Description
    The Ring-Lok™ Modular Bi-Polar System is intended for use in combination with the previously cleared femoral components including Rig-Fix™ Hip Stem (K072101), C-fit Performa (K923898) or the Stability Hip Stem (K915787 and K934457)). The Ring-Lok™ Modular Bipolar System consists of a factory assembled UHMWPE liner in a cobalt chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 62 mm, in 1mm increments, to properly fit the patient anatomy. The inner diameter mates with a 22.225, 26 or 28 mm diameter femoral head. Implant International supplies Ring-Lok™ Bi-Polar Instrumentation for use with the Ring-Lok™ Modular Bi-Polar System.
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    K Number
    K071583
    Device Name
    CERMET III ACETABULAR CUP SYSTEM
    Date Cleared
    2007-07-25

    (47 days)

    Product Code
    Regulation Number
    888.3353
    Why did this record match?
    Applicant Name (Manufacturer) :

    IMPLANTS INTERNATIONAL, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CER-MET™ III Acetabular Cup System is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.
    Device Description
    The CER-MET™ III Acetabular Cup System is a non-cemented acetabular cup system with a complete assortment of neutral and 10° hooded poly inserts as well as acetabular screws and screw hole covers (screw hole occluders).
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