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510(k) Data Aggregation

    K Number
    K213272
    Device Name
    Formus Hip
    Manufacturer
    Formus Labs, Ltd
    Date Cleared
    2023-03-31

    (547 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Formus Labs, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Formus Hip is a preoperative surgical planning software. It is intended to assist qualified medical professionals in the preoperative planning of orthopedic surgical procedures.
    Device Description
    Formus Hip is a semi-automated Software as a Medical Device (SaMD) that allows pre-operative planning of primary total hip arthroplasty in real time using the Zimmer Biomet Taperloc G7 system. Using a series of algorithms, the software creates a 3D model and relevant measurements derived from the patient's pre-dimensioned CT scan. Formus Hip generates a 3D model without any user input. Additional algorithms fit the femoral stem and acetabular cup based on the patient anatomy. The software allows the user to adjust the plan interactively to achieve the desired clinical targets.
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