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510(k) Data Aggregation

    K Number
    K252037

    Validate with FDA (Live)

    Device Name
    CUVIS-joint (CJ150)
    Manufacturer
    Curexo, Inc.
    Date Cleared
    2026-03-25

    (268 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K191369,K203040
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CUVIS-joint is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.

    The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty (TKA).

    The CUVIS-joint is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and effective and where references to rigid anatomical structures may be made.

    The CUVIS-joint is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The CUVIS-joint facilitates accurate positioning of TKA implants, relative to these alignment axes.

    The CUVIS-joint is compatible with the following Knee Implant System:
    -United U2 Knee System

    Device Description

    The CUVIS-joint is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require total joint arthroplasty. The device is intended as an alternative to manual template planning and preparation of the bone with patients requiring primary total knee arthroplasty (TKA).

    The CUVIS-joint consists of two main components: 1) the Planner which is a three-dimensional (3D) preoperative planning workstation which uses preoperative CT scans of patient anatomy to aid a surgeon in planning the position and orientation of the implant components relative to 3D models of the patient's anatomy, and 2) the Robotic Arm Tool which executes the surgical plan and includes a an electromechanical arm, an arm base including control electronics and computer, optical tracking system, a display monitor, operating software, pendant control, and tools and accessories. When used according to the Instructions for Use (IFU), the CUVIS-joint enables precise implant positioning possible before and during TKA surgical procedures.

    AI/ML Overview

    N/A

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