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510(k) Data Aggregation

    K Number
    K242121
    Device Name
    mBôs (Monogram mBôs TKA System)
    Date Cleared
    2025-03-14

    (238 days)

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

    Monogram Orthopaedics, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The mBôs TKA system is indicated for use in surgical knee procedures on adults in which the 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 Knee Arthroplasty (TKA) The implant systems compatible with the system: mPress™ Total Knee System: mPress™ TL: Cementless mPress™ TC: Cemented Each Implant System includes the Cruciate Retaining (CR), Cruciate Substituting (CS), and Posterior Stabilized (PS) implant types.
    Device Description
    The mBôs TKA system is a stereotactic planning and implementation device designed to assist orthopedic surgeons in treating patients requiring primary total knee arthroplasty (TKA) surgeries. It is an alternative to manual template planning for femur and tibia bone for surgical preparation for TKA procedures. The device's hardware comprises a robotic arm mounted on a stabilized cart with an integrated sagittal saw-based cutting system. The robot cart houses the necessary electromechanical components. It provides power and communications to an infrared (IR) based optical tracker, a display screen, a foot pedal, a touchscreen, a sagittal saw cutting tool, and protective stops. Additionally, the system includes dedicated instrumentation, tools, accessories, and proprietary software for operating and case planning. The mBôs TKA system proprietary software suite (mSuite™) is comprised of the following: mPower® Case Management Application (CMA) mPower® Embedded System Applications
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