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510(k) Data Aggregation

    K Number
    K200587
    Device Name
    VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder
    Manufacturer
    OrthoSensor, Inc.
    Date Cleared
    2020-08-25

    (172 days)

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

    OrthoSensor, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VERASENSE for Exactech Equinoxe is for any medical condition in which reverse Total Shoulder Arthroplasty (rTSA) would be indicated. For use as a tool for measuring load magnitude and displaying center of the humeral component on the glenosphere component. The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement. The VERASENSE for Exactech Equinoxe is sterile, for single patient use.
    Device Description
    The VERASENSE for Exactech Equinoxe device is an intelligent disposable humeral insert trial that measures dynamic loads on the humeral insert and wirelessly transmits the measured load data to the LinkStation MINI and LinkStation MINI Evaluation Kit with VERASENSE Software Application for Shoulder (VSA-S). The VSA-S provides the surgeon with a graphical and numerical presentation of the glenohumeral load magnitude and center of load (COL) location (weighted average) from the humeral to glenoid components. Individual VERASENSE for Exactech Equinoxe devices are packaged sterile, for single patient use with a shim set for thickness adjustments.
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    K Number
    K200665
    Device Name
    VERASENSE for Stryker Triathlon
    Manufacturer
    OrthoSensor, Inc.
    Date Cleared
    2020-04-12

    (30 days)

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

    OrthoSensor, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VERASENSE is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated. For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. VERASENSE is sterile, for single patient use.
    Device Description
    The VERASENSE device is an intelligent disposable tibial insert trial that measures dynamic loads in the medical and lateral compartments of the knee and wirelessly transmits the measured load data to the LinkStation MINI and LinkStation MINI Evaluation Kit with VERASENSE Software Application (VSA). The VSA provides the surgeon with a graphical and numerical presentation of the load magnitude and center of load (COL) location (weighted average) of the femoral to the tibial component in each of the medial and lateral compartments of the knee for reference only. Individual VERASENSE devices are packaged sterile, for single patient use with a shim set for thickness adjustments.
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    K Number
    K193580
    Device Name
    VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left
    Manufacturer
    OrthoSensor, Inc.
    Date Cleared
    2020-04-01

    (100 days)

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

    OrthoSensor, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VERASENSE for Zimmer Biomet Persona is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated. For use as a tool to measure implant alignment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE for Zimmer Biomet Persona is sterile, for single patient use.
    Device Description
    VERASENSE for Zimmer Biomet Persona provides a means to measure implant alignment and dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA). The VERASENSE for Zimmer Biomet Persona consists of a knee sensor device and the following required accessories: LinkStation MINI or LinkStation MINI Evaluation Kit and VERASENSE Software Application (VSA). The required accessories are intended to support the performance of the VERASENSE for Zimmer Biomet Persona parent device. Individual VERASENSE for Zimmer Biomet Persona devices are packaged sterile, for single patient use with a shim set for thickness adjustments. The required accessories are not packaged sterile and are reusable. VERASENSE for Zimmer Biomet Persona devices are implant system specific due to variations in implant design and is compatible with the Zimmer Biomet Persona Knee System. The VERASENSE for Zimmer Biomet Persona is an intelligent disposable tibial insert that measures dynamic loads in the medial and lateral compartments of the knee and angular velocity and acceleration for the alignment functionality. The data from the sensor is wirelessly transmitted to the LinkStation MINI or LinkStation MINI Evaluation Kit which runs the VSA and is located outside the sterile field in the operating room. The VSA provides the surgeon with a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee, center of load (COL) from the femoral to the tibial component in each of the medial and lateral compartments of the knee for reference only, static measurement of the coronal alignment of the tibial resection relative to the patient specific tibial reference axis defined by the system registered anatomical landmarks, and numerical value of the varus/valgus tibial mechanical alignment.
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    K Number
    K180459
    Device Name
    VERASENSE for Zimmer Biomet Persona
    Manufacturer
    OrthoSensor, Inc.
    Date Cleared
    2018-06-07

    (107 days)

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

    OrthoSensor, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VERASENSE is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated. For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE is sterile, for single patient use.
    Device Description
    VERASENSE provides a means to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA). The VERASENSE consists of a knee sensor device and the following required accessories: LinkStation MINI or LinkStation Evaluation Kit and VERASENSE Software Application (VSA). The required accessories are intended to support the performance of the VERASENSE parent device. The LinkStation MINI / LinkStation MINI Evaluation Kit is capable of running the VSA and communicating wirelessly with the VERASENSE from outside the sterile field in the operating room. Individual VERASENSE devices are packaged sterile, for single patient use with a Shim Set for thickness adjustments. The required accessories are not packaged sterile and are reusable. The VERASENSE device is an intelligent disposable tibial insert that measures dynamic loads in the medial and lateral compartments of the knee and wirelessly transmits the measured load data to the LinkStation MINI or LinkStation MINI Evaluation Kit. The VSA provides the surgeon with a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee. The VSA also provides location of the center of load (COL) from the femoral to the tibial component in each of the medial and lateral compartments for reference only. VERASENSE devices are implant system specific due to variations in implant design. VERASENSE is compatible with the following implant systems: - VERASENSE for Biomet Vanguard - VERASENSE for Stryker Triathlon - VERASENSE for Zimmer NexGen - VERASENSE for Smith & Nephew Legion - VERASENSE for Smith & Nephew Journey II - VERASENSE for Zimmer Biomet Persona
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    K Number
    K150372
    Device Name
    VERASENSE Knee System
    Manufacturer
    OrthoSensor, Inc.
    Date Cleared
    2016-04-15

    (427 days)

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

    OrthoSensor, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VERASENSE Knee System is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated. For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE Knee System is sterile, for single patient use.
    Device Description
    The VERASENSE Knee System provides a means to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA) intra-operatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface and angular positional information (such as alignment, varus/valgus, posterior, and anterior slope positioning, etc.) after insertion into the space between the tibia and femur. The VERASENSE™ Knee System is an intra-operative device for use in primary or revision total knee arthroplasty (TKA), where all patient contacting components are made of biocompatible polycarbonate and adhesive. The VERASENSE™ Knee System is an intelligent disposable tibial insert that wirelessly transmits the measured data to the OrthoSensor LinkStation for surgeon visualization. Individual VERASENSE™ devices are packaged sterile, for single patient use with a Shim Set for thickness adjustments. The OrthoSensor LinkStation and VERASENSE™ Knee System Software Application are required for use of the VERASENSE™ Knee System device. The LinkStation contains a computer and all peripheral equipment required to display the measured data by providing a graphical and numerical presentation of the loads in both the medial and lateral compartments of the knee. VERASENSE™ Knee System devices are implant system specific due to variations in implant design.
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    K Number
    K131767
    Device Name
    ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
    Manufacturer
    ORTHOSENSOR, INC.
    Date Cleared
    2013-11-08

    (144 days)

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

    ORTHOSENSOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE™ Knee System is sterile, for single patient use.
    Device Description
    OrthoSensor VERASENSE™ Knee System provides a means to dynamically balance the knee during knee replacement surgery intra-operatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface and angular positional information (such as alignment, varus/valgus, posterior and anterior slope positioning, etc.) after insertion into the space between the tibia and the femur.
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    K Number
    K130380
    Device Name
    ORTHOSENSOR KNEE BALANCER
    Manufacturer
    ORTHOSENSOR, INC.
    Date Cleared
    2013-06-13

    (119 days)

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

    ORTHOSENSOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The Knee Balancer is sterile, for single patient use.
    Device Description
    OrthoSensor Knee Balancer provides a means to dynamically balance the knee during knee replacement surgery intra-operatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface and angular positional information after insertion into the space between the tibia and the femur.
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    K Number
    K090474
    Device Name
    ORTHOREX INTRA-OPERATIVE LOAD SENSOR
    Manufacturer
    ORTHOSENSOR, INC.
    Date Cleared
    2009-10-19

    (237 days)

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

    ORTHOSENSOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The force sensor is sterile, for single patient use.
    Device Description
    Orthosensor Intra-Operative Load Sensor (IOLS) system provides a means to dynamically balance the knee during knee replacement surgery intraoperatively. The system includes an instrumented trial tibial insert comprising an array of load sensors that measure the forces applied on its surface after insertion into the space between the tibia and the femur.
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