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510(k) Data Aggregation

    K Number
    K970346
    Device Name
    PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT
    Date Cleared
    1997-02-19

    (20 days)

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

    KAIROS ORTHOPAEDICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PSI Hip Femoral Component with HA Coating is indicated for uncemented use as the femoral component in total hip arthroplasty (THA) for replacing the hip joint of patients whose hip joint has been damaged by degenerative joint disease, fracture or the failure of previous arthroplasty. Each PSI stem is specifically designed for clinical cases where the patient would see added benefit from a femoral component designed to match the natural bone geometry of the femur.
    Device Description
    The Kairos™ Orthopaedics Patient Specific Implant (PSI) Hip Femoral Component with HA Coating is designed using the patient's natural bone geometry to construct an implant to better fit and fill the patient's femoral canal relative to other commercially available standard hip stems. Since each stem is matched to a particular patient, a precise device description cannot be provided, as the device design will vary from patient to patient depending upon their unique, naturally occurring bone geometry. Kairos™ Orthopaedics specifies eight design parameters that define an "envelope" of dimensional limits within which all PSI stems are defined.
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