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510(k) Data Aggregation

    K Number
    K200642
    Device Name
    OrthAlign Plus System
    Manufacturer
    OrthAlign, Inc.
    Date Cleared
    2020-04-10

    (30 days)

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

    OrthAlign, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthAlign Plus® system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instructures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® system facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length discrepancy in Total Hip Arthroplasty. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty - · Total Hip Arthroplasty: Anterior/Posterior - · Unicompartmental Knee Arthroplasty: Tibial transverse resection The OrthAlign HipAlign® Sterile Pin Pack is indicated for use with the OrthAlign Plus® System. Intended Use: The OrthAlign® HipAlign® Sterile Pin Pack is intended to be used with the OrthAlign Plus® system specific to Total Hip Arthroplasty.
    Device Description
    The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display anqular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes, The OrthAlign HipAliqn® Sterile Pin Pack is a set of sterile, single use pins used in conjunction with the OrthAlign Plus® system of instruments and electronics. The OrthAlign® HipAlign® Pin Pack includes: - . Pelvic Fixation pins: 4.0mm in diameter and 90mm to 140mm in length - Pelvic Fixation pins: 5mm in diameter and 170mm in length - . Femoral registration markers: 4.0mm to 4.5mm in diameter and 16mm to 25mm in length
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    K Number
    K172462
    Device Name
    OrthAlign Plus System
    Manufacturer
    OrthAlign, Inc.
    Date Cleared
    2017-11-22

    (100 days)

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

    OrthAlign, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty. Ligament balancing is provided by the OrthAlign Plus® System in primary or revision Total Knee Arthroplasty. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty - Total Hip Arthroplasty: Anterior/Posterior - Unicompartmental Knee Arthroplasty: Tibial transverse resection - Ligament Balancing
    Device Description
    The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.
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    K Number
    K171780
    Device Name
    OrthAlign Plus System
    Manufacturer
    OrthAlign, Inc.
    Date Cleared
    2017-07-11

    (26 days)

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

    OrthAlign, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instructures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty - · Total Hip Arthroplasty: Anterior/Posterior - · Unicompartmental Knee Arthroplasty: Tibial transverse resection
    Device Description
    The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.
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    K Number
    K163379
    Device Name
    KneeAlign 2 System
    Manufacturer
    OrthAlign, Inc.
    Date Cleared
    2017-03-02

    (91 days)

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

    OrthAlign, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KneeAlign® system is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic surgical procedures. The KneeAlign system facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes. Orthopedic surgical procedures include but are not limited to: - · Total Knee Arthroplasty - · Unicompartmental Knee Arthroplasty Tibial Transverse Resection
    Device Description
    The KneeAlign® 2 System is a non-invasive computer assisted surgical navigation system for use in knee arthroplasty procedures. The KneeAlign® 2 System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The KneeAlign® 2 System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. In total knee arthroplasty procedures, the device assists the surgeon in: - . Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur. - Establishing the mechanical axis of the tibia, determining the varus/valgus . angle and the posterior slope angle of the cutting block relative to the tibia. In unicompartmental knee arthroplasty procedures, the device assists the surgeon in: - Establishing the mechanical axis of the tibia, determining the varus/valgus . angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection. The KneeAlign® 2 System comprises a single use computer module and reusable instrumentation.
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    K Number
    K162962
    Device Name
    OrthAlign Plus System
    Manufacturer
    OrthAlign, Inc.
    Date Cleared
    2017-01-23

    (91 days)

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

    OrthAlign, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty. Example orthopedic surgical procedures include but are not limited to: - · Total Knee Arthroplasty - · Total Hip Arthroplasty: Anterior/Posterior - · Unicompartmental Knee Arthroplasty: Tibial transverse resection
    Device Description
    The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.
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    K Number
    K153237
    Device Name
    OrthAlign Plus System
    Manufacturer
    OrthAlign, Inc.
    Date Cleared
    2016-03-01

    (113 days)

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

    OrthAlign, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty: Posterior. Example orthopedic surgical procedures include but are not limited to: - · Total Knee Arthroplasty - · Total Hip Arthroplasty: Anterior/Posterior - · Unicompartmental Knee Arthroplasty: Tibial transverse resection
    Device Description
    The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.
    Ask a Question

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