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510(k) Data Aggregation

    K Number
    K241298
    Device Name
    QUADSENSE
    Manufacturer
    Eventum Orthopaedics Ltd
    Date Cleared
    2024-10-04

    (149 days)

    Product Code
    ONN
    Regulation Number
    882.4560
    Why did this record match?
    Product Code :

    ONN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quadsense is indicated for use in primary Total Knee Arthroplasty (TKA), where the patella is resurfaced. For use as a comparative tool to measure patellofemoral joint force. Quadsense sensor is sterile, for single patient use. The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement.
    Device Description
    The QUADSENSE system has been designed to allow surgeons to compare forces in the patellofemoral joint during total knee surgery. The QUADSENSE system includes a sensor that attaches to the patella, adjustment shims that attach to the sensor, a control puck, and a touchscreen Panel PC with QUADSENSE software. The patella sensor can take readings of Medial, Lateral, Superior, and Inferior loads during range of motion trials. The sensor records data that is displayed on the Panel PC in real time. The Panel PC remains outside of the sterile field, and the software workflow can be controlled by the surgeon using the control puck, within the sterile field. The Panel PC collects and temporarily stores sensor reading data so the surgeon can view the sensor readings of force through the patellofemoral joint during different stages of the surgical procedure. The sensor has been designed to attach to the patella at the start of the surgical procedure, following a conservative resection of the patella. This allows the surgeon to take a sensor reading of the patient's force through the patellofemoral joint during range of motion trials, prior to the resurfacing of the femur and the tibia. The surgeon can then take a reading of the force through the patellofemoral joint with the trial femoral and tibial components in situ. This allows the surgeon to assess how the new position of the femoral and tibial components has impacted the patient's force through the patellofemoral joint by comparing the reference reading taken prior to resurfacing to the reading(s) taken following trial implant insertion. The sensor is supplied with several shims with different thicknesses and angles. By changing the thickness, rotation angulation parameters of the shim attached to the surgical procedure the surgeon can assess how change in patella thickness or angulation will impact the force through the patellofemoral joint.
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    K Number
    K242616
    Device Name
    Lantern® Hip
    Manufacturer
    OrthAlign, Inc
    Date Cleared
    2024-10-03

    (30 days)

    Product Code
    ONN
    Regulation Number
    882.4560
    Why did this record match?
    Product Code :

    ONN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lantern® Hip is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic surgical procedures. Lantern® Hip facilitates the accurate positioning of implants relative to these alignment axes. The surgeon in controlling leg length and offset discrepancies. The Lantern® Hip is indicated for Total Hip Arthroplasty with an anterior hip approach (Direct Anterior Approach) and the patient in the supine position.
    Device Description
    The Lantern® Hip (modified device) 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 Lantern® Hip 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. Lantern® Hip facilitates the accurate positioning of implants relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies The Lantern® Hip consists of the sterile, single-use Lantern® Hip navigation unit (packaging includes reference sensor, CR2 battery and femur sensor battery), the non-sterile reusable reference sensor, the non-sterile reusable femur sensor, and associated non-sterile reusable instrumentation. The Lantern® Hip unit is sterile unless the sterile packaging is opened or damaged.
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    K Number
    K220830
    Device Name
    TrueBalance™ Surgical System
    Manufacturer
    These Three Medical, LLC
    Date Cleared
    2022-09-15

    (177 days)

    Product Code
    ONN
    Regulation Number
    882.4560
    Why did this record match?
    Product Code :

    ONN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TrueBalance™ Surgical System 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. TrueBalance™ Surgical System is completely reusable with the exception of the Ultra-Thin Force Sensor which is single use.
    Device Description
    TrueBalance™ Surgical System provides a means to measure implant alignment and dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA). TrueBalance™ Surgical System consists of seven components and one optional component: - Electronic Module, 1. - 2. Ultra-Thin Force Sensor, - Multifunction Alignment Handle, 3. - 4. Sensor Covers (8 sizes), - 5. Alignment Rod, - Sterilization Tray, and 6. - 7. TrueBalance™ Software Application (TSA) and Display (iPad) - 8. (Optional) Off-the-shelf Tablet Floor Stand for iPad The TrueBalance™ Surgical System Electronic Module and hardware components are steam sterilizable via autoclave and reusable via a Sterilization Tray. TrueBalance™ Surgical System Ultra-Thin Force Sensor is single use, packaged non-sterilizable via autoclaye. The TrueBalance™ Surgical System Electronic Module is steam sterilizable via autoclave in either the Sterilization Tray or standard autoclavable pouches. TrueBalance™ Surgical System measures dynamic loads in the medial and lateral compartments of the knee and static angular measurements for the alignment functionality. The data from the Ultra-Thin Force Sensor and embedded accelerometer is wirelessly transmitted to the TrueBalance™ Software Application (TSA) and Display (iPad) which is located outside the sterile field in the operating room.
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    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?
    Product Code :

    ONN

    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?
    Product Code :

    ONN

    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?
    Product Code :

    ONN

    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?
    Product Code :

    ONN

    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
    K162237
    Device Name
    XO1 Knee Balancing System
    Manufacturer
    XPANDORTHO, INC.
    Date Cleared
    2017-04-25

    (259 days)

    Product Code
    ONN
    Regulation Number
    882.4560
    Why did this record match?
    Product Code :

    ONN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XO1 Knee Balancing System is intended for use as a tool for adjustment of soft tissue to reduce instability from flexion gap asymmetry in total knee replacement procedures.. The XO1 Knee Balancing System requires a resected tibial bone and may only be used with an intact femur, trial femoral implant. The force sensor is sterile, for single patient use.
    Device Description
    Not Found
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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?
    Product Code :

    ONN

    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
    K132104
    Device Name
    ELIBRA SOFT-TISSUE FORCE SENSOR
    Manufacturer
    Kamm & Associates
    Date Cleared
    2014-03-21

    (256 days)

    Product Code
    ONN
    Regulation Number
    882.4560
    Why did this record match?
    Product Code :

    ONN

    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
    The device consists of one unit, containing the force sensor and an electronic display. The eLIBRA® Soft-Tissue Force Sensor for a total knee replacement is a single use battery powered device designed to show relative forces on the integrated display. The eLIBRA® Unit is a non-reusable battery powered device designed to receive an electronic signal from the integrated force sensor. The unit displays a number from 0-20 for both the medial and lateral compartments in the knee joint to aid the surgeon in balancing soft tissue structures during a total knee arthroplasty (TKA).
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