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510(k) Data Aggregation

    K Number
    K220774
    Device Name
    RobPath® Total Hip Application
    Date Cleared
    2022-12-09

    (268 days)

    Product Code
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hangzhou Lancet Robotics Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RobPath® Total Hip Application is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RobPath® Total Hip Application is indicated for use in a surgical hip procedure in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: • Total Hip Arthroplasty (THA)
    Device Description
    The proposed RobPath® Total Hip Application is a semi-active robotic system. Pre-operative CT imaging is used to generate a 3D model of the native hip joint. An initial plan is created using selected CT landmarks and superimposed onto the 3D reconstruction. The surgeon is then able to fine-tune this to ensure optimal templating of component size and alignment, thus allowing the desired restoration of hip biomechanics, bone coverage, component positioning and leg-length correction. The robotic arm is not fully automated but based on haptic feedback, so the surgeon retains partial control during the implantation.
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