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510(k) Data Aggregation

    K Number
    K243975
    Device Name
    Knee+
    Manufacturer
    Pixee Medical
    Date Cleared
    2025-03-20

    (87 days)

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

    Pixee Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Knee+ is a stereotaxic system including an intraoperative software as a medical device and surgical instruments. Knee+ is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting computed mechanical axis. The Knee+ includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods.
    Device Description
    Knee+ is a navigation system dedicated to orthopaedic kneePlus software and KneeTools reusable surgical instruments. The main purpose of Knee+ is to assist the surgeon during primary Total Knee Arthroplasty (TKA) interventions. Knee+ provides information to help locate and orientate the main femoral and tibial cutting planes as required during TKA. Knee+ allows the surgeon to adjust the orientation of the cutting plane orientation and the level of resection by collecting anatomical references during the TKA procedure using surgical instruments. The software frame the instruments which include markers. All collected coordinates are treated by software algorithms to provide the surgeon with relevant orientation and location of the tracked cutting guide. Knee+ software is installed on a wearable Head Mounted Device (HMD) which includes a camera, a computer and displays intraoperative information to the user. A near-eye display allows the HMD screen when needed.
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    K Number
    K233899
    Device Name
    Knee+
    Manufacturer
    Pixee Medical
    Date Cleared
    2024-03-08

    (88 days)

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

    Pixee Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Knee+ is a stereotaxic system including an intraoperative software as a medical device and surgical instruments. Knee+ is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting computed mechanical axis. The Knee+ includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods.
    Device Description
    Knee+ is a navigation system dedicated to orthopaedic knee surgery. It includes KneePlus software and KneeTools reusable surgical instruments. The main purpose of Knee+ is to assist the surgeon during primary Total Knee Arthroplasty (TKA) interventions. Knee+ provides information to help locate and orientate the main femoral and tibial cutting TKA. Knee+ allows the surgeon to adjust the orientation of the cutting plane orientation and the level of resection by collecting anatomical references during the TKA procedure using surgical instruments. The software locates in a 3D reference frame the instruments which include markers. All collected coordinates are treated by software algorithms to provide the surgeon with relevant orientation and location of the tracked cutting guide. Knee+ software is installed on a wearable Head Mounted Device (HMD) which includes a camera and displays intraonerative information to the user. A near-eye display allows the HMD screen or the field of view when needed.
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    K Number
    K230789
    Device Name
    Knee+
    Manufacturer
    Pixee Medical
    Date Cleared
    2023-04-21

    (30 days)

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

    Pixee Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Knee+ is a stereotaxic system including an intraoperative software as a medical device and surgical instruments. Knee+ is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting computed mechanical axis. The Knee+ includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods.
    Device Description
    The main purpose of Knee+ is to assist the surgeon during the primary Total Knee Replacement (TKR) intervention. Knee+ includes software and surgical instruments. Knee+ provides information to help locate and orientate the main femoral and tibial cutting planes as required in knee replacement surgery. Knee+ allows the surgeon to adjust the cutting plane orientation and the resection level. This includes means for the surgeon to collect anatomical references during the TKR intervention using the surgical instruments. The software locates in a 3D reference frame the instruments which include markers. All collected coordinates are treated by software algorithms to provide the surgeon with relevant orientation of the tracked cutting guide. Knee+ software is installed on a wearable Head Mounted Device (HMD) which includes a camera and displays intraoperative information to the user. A near-eye display allows the surgeon to look at the HMD screen or the field of view when needed.
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    K Number
    K220104
    Device Name
    Knee+
    Manufacturer
    Pixee Medical
    Date Cleared
    2022-09-01

    (232 days)

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

    Pixee Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Knee is a stereotaxic system including an intraoperative software as a medical device and surgical instruments. Knee is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting guide regarding computed mechanical axis. The Knee includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods.
    Device Description
    The main purpose of Knee* is to assist the surgeon during the primary Total Knee Replacement (TKR) intervention. Knee* includes software and surgical instruments. Knee* provides information to help locate and orientate the main femoral and tibial cutting planes as required in knee replacement surgery. Knee* allows the surgeon to adjust the cutting plane orientation and the resection level. This includes means for the surgeon to collect anatomical references during the TKR intervention using the surgical instruments. The software locates in a 3D reference frame the instruments which include markers. All collected coordinates are treated by software algorithms to provide the surgeon with relevant orientation of the tracked cutting guide. Kneet software is installed on a wearable Head Mounted Device (HMD) which includes an embedded camera and displays intraoperative information to the user. This near-eve display allows the surgeon to look at the HMD screen or the field of view when needed.
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    K Number
    K213922
    Device Name
    FX SPS
    Manufacturer
    Pixee Medical
    Date Cleared
    2022-07-22

    (219 days)

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

    Pixee Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FX SPS is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.
    Device Description
    FX SPS is a preoperative standalone web-based medical software used for the planning of primary shoulder replacement from CT-images. It comprises a secure database which enables the patient's cases management and the access to the planning interface. Preliminary to the planning, a manual segmentation needs to be performed from the patient's CT-images. The segmentation process consists in building 3D bone models of the patient's shoulder and positioning anatomic landmarks on it. Once these data are generated, their compliance is checked. They are then imported into the FX SPS's database making the planning available for the surgeon. The planning step involves virtually positioning of the shoulder prosthesis on the 3D reconstruction of the patient's shoulder. On that purpose, the surgeon chooses implants from a library of implants. Afterwards, he selects the size of the implant more suitable to the joint and he can move prosthesis components in all directions. Once the positioning of the implant is satisfying, he validates the planning to generate a planning report. During surgery, he will have at its disposal the planning report comprising preoperative and planned parameters.
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    K Number
    K202750
    Device Name
    Knee+
    Manufacturer
    Pixee Medical
    Date Cleared
    2021-04-21

    (212 days)

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

    Pixee Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Knee is a stereotaxic system including a dedicated intraoperative standalone software and surgical instruments. Knee " is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting guide regarding computed mechanical axis. The Knee includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods.
    Device Description
    The main purpose of Knee* is to assist the surgeon during the primary Total Knee Replacement (TKR) intervention. Knee* includes KneePlus software and reusable KneeTools instruments. Knee* provides information to help locate and orientate the main femoral and tibial cutting planes as required in knee replacement surgery. Knee* allows the surgeon to adjust the cutting plane orientation and the resection level. This includes means for the surgeon to collect anatomical references during the TKR intervention using the KneeTools instruments. KneePlus software locates in a 3D reference frame the KneeTools instruments which include markers. All collected coordinates are treated by KneePlus algorithms to provide to the surgeon relevant orientation of the tracked cutting guide. The KneePlus software is installed on a monocular near-eye HMD and provides the field of vision of the embedded HMD camera with additional information on an opaque 2D OLED screen. The surgeon uses this near-eye display in a very similar way he uses a traditional monitor such as the primary predicate device (Navitrack® System - OS Knee Universal, K110054): the surgeon can choose to look at the screen only when needed. The near-eye display is similar to what would be displayed on the screen of a tablet, smart phone or laptop positioned on a table next to the user.
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