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510(k) Data Aggregation

    K Number
    K213380
    Device Name
    360CAS
    Manufacturer
    Kico Knee Innovation Company Pty Limited
    Date Cleared
    2022-01-11

    (90 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K102251,K162341,K162937
    Why did this record match?
    Reference Devices :

    K102251

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 360CAS is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided surgical procedures.

    The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure, such as the pelvis, femur, or tibia, can be identified.

    The 360CAS Knee is indicated for the following surgical procedures:

    • Total Knee Arthroplasty (TKA)
    • For conditions of the knee joint in which the use of computer assisted surgery may be appropriate

    The 360CAS Hip is indicated for the following surgical procedures:

    • Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used
    • For conditions of the hip joint in which the use of computer assisted surgery may be appropriate
    Device Description

    The 360 Computer Assisted Surgery (360CAS) is a stereotaxic surgical navigation system for orthopaedic surgical procedures. The 360CAS is intended to be used as a planning and intraoperative quidance system with any manufacturers implant in open or percutaneous orthopaedic surgical procedures. The 360CAS uses optical tracking technology that allows surgeons to map a patient's morphology, navigate surgical instruments and implants and assess the state of the joint throughout the surgery. The system consists of four main components: 360CAS navigation software, which consists of two modules: 360CAS Knee and 360CAS Hip, surgical instruments, spatial tracking components and a navigation cart. 360CAS Knee is a 360CAS navigation software for knee replacement surgery. 360CAS Hip is a 360CAS navigation software for hip replacement surgery. The navigation software interfaces with the optical trackers which are attached to navigation instruments (e.g. pointer, bone fixator(s)).

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    System Accuracy (Knee)The system enables the determination of the mechanical axes of the lower limb as well as cut and component alignment with a mean translational error of
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