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510(k) Data Aggregation

    K Number
    K253764

    Validate with FDA (Live)

    Device Name
    ENOS Software Guided External Fixation System
    Manufacturer
    Disior, Ltd.
    Date Cleared
    2026-02-26

    (93 days)

    Product Code
    OSN
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K190069,K140550
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ENOS Software Guided External Fixation System application is used with the Paragon 28 Monkey Rings™ External Fixation System for the treatment of traumatic or reconstructive deformities within the indications for use of the Monkey Rings External Fixation System. It is used to generate a prescription of strut adjustments to provide to the patient.

    Device Description

    The ENOS Software Guided External Fixation System (also known as Smart Monkey Rings) is a cloud-based medical device software system that assists orthopedic surgeons in planning patient-specific deformity corrections for use with the Monkey Rings Circular External Fixation System. The surgeon enters anatomical alignment values, hardware configuration parameters, and treatment objectives, and the software's algorithm processes these inputs together with the mechanical characteristics of the Monkey Rings hardware to generate a patient-specific strut adjustment schedule.

    AI/ML Overview

    N/A

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