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510(k) Data Aggregation

    K Number
    K223351
    Device Name
    Naviswiss Knee
    Manufacturer
    Date Cleared
    2023-01-31

    (90 days)

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

    Naviswiss AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Naviswiss Knee Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system aids the surgeon in performing intra-operative measurements of femoral and tibial alignment axes to assist in executing the distal femoral and proximal tibial resections. The equipment is intended for use by trained surgeons in operating theaters.
    Device Description
    The Naviswiss Knee is a surgical navigation system which assists the orthopaedic surgeon during the implantation of an artificial knee joint. It consists of a navigation unit which is first used to register the patient's anatomy. Subsequently the navigation system supports the surgeon in guiding the surgical instruments with the implant according to the pre-operative planning. The navigation unit includes an infrared stereo camera which measures the position and orientation of small NAVItags.
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    K Number
    K211429
    Device Name
    NAVIPLAN - CT Planning Software for Total Hip Replacement
    Manufacturer
    Date Cleared
    2021-10-05

    (151 days)

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

    Naviswiss AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Naviplan is indicated for pre-operative planning for surgical procedures related to hip, such as artificial joint replacement (3D templating of implants).
    Device Description
    NAVIPLAN - CT Planning Software for Total Hip Replacement, or "Naviplan", is a software which assists in the pre-operative planning of total hip replacement surgery based on three dimensional CT-images (computed tomography). The Naviplan allows the user to process CT DICOM images which are automatically segmented. The user gets an automatic identification of anatomical landmarks as an output, which is normally used in hip surgery. The Naviplan automatically computes an initial planning (implant type and size selection as well as positioning) which can be inspected and edited by the user until the optimal configuration is established. The user can export the plan as a pdf report and as a navigation archive to be used with the Naviswiss Hip Navigation System. The export steps are optional, whereas the report serves a documentation purpose.
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    K Number
    K193094
    Device Name
    Naviswiss Hip Navigation System
    Manufacturer
    Date Cleared
    2020-06-10

    (216 days)

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

    Naviswiss AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Naviswiss Hip Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system is only compatible with acetabular cup impactors that have a parallel and straight segment. The system aids the surgeon in performing intra-operative measurements of leg length, offset, and cup inclination/anteversion. An example of a stereotaxic orthopedic surgical procedure includes Total Hip Arthroplasty: Lateral/Supine. The equipment is intended for use by trained surgeons in operating theaters.
    Device Description
    The Naviswiss Hip Navigation System is an image-free surgical navigation system intended to assist the orthopedic surgeon during the implantation of an artificial joint (hip). The device consists of a handheld navigation device, used to register the patient's anatomy into a software platform. Subsequently the navigation system helps the surgeon maneuver the surgical instruments with precision. Thus, the surgeon can position the implant in accordance to pre-operative planning. The Naviswiss Hip Navigation System is comprised of two major sub-systems: the Naviswiss Hip (M42) and Naviswiss Platform (M59). The Naviswiss Hip (M42) is composed of: - . NAVItags used for reference and registration - . Ancillary instruments - . Application Software The Naviswiss Platform (M59) is composed of: - . Computer - Camera ● - . Software The M42 employs the base computing, power supply, and programing in the M59 Platform. The NAVItags allow the surgeon to determine anatomical landmarks or navigate an instrument. The camera utilizes application and tracking software to guide the surgeon through a workflow process for the surgery. The camera is covered by a sterile, single use drape for use of the navigation device in a sterile environment.
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