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510(k) Data Aggregation

    K Number
    K190633
    Device Name
    NanoOrtho NanoKnee® System
    Manufacturer
    NanoOrtho, LLC
    Date Cleared
    2019-12-20

    (283 days)

    Product Code
    HRY, HSX, NJD
    Regulation Number
    888.3530
    Why did this record match?
    Applicant Name (Manufacturer) :

    NanoOrtho, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NanoOrtho NanoKnee® System is indicated for restoring either compartment of a knee that has been affected by the following: 1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. Correction of femoral deformity; 3. Revision procedures where other treatments or devices have failed; and 4. Treatment of fractures that are unmanageable using other techniques. The NanoOrtho NanoKnee® System components are single use and are intended for implantation with or without bone cement.
    Device Description
    The NanoOrtho NanoKne® is a unicompartmental knee system that includes porous coated and non-porous coated, cast CoCr, symmetric femoral components in sizes 1-6; and Ti6Al4V, symmetric, porous coated and non-porous coated tibial baseplate components in sizes 1-6. The tibial inserts are offered in standard UHMWPE, symmetric design, Constrained+, in sizes 1-6 and 5 thicknesses per size 9,10,11,12,14mm.
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