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510(k) Data Aggregation

    K Number
    K090658
    Device Name
    SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2010-03-03

    (356 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K013697,K001479,K990799,K021319
    Why did this record match?
    Reference Devices :

    K013697, K001479, K990799, K021319

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

    Synthes External Fixation Devices, MR Conditional are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.

    Synthes Medium External Fixation is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures.

    Synthes Distal Radius Fixator is intended for the fixation of the distal radius.

    Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius.

    Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress must be limited due to persistent ligament instability. The indications for guided joint bridging with external fixators are:

    • Delayed treatment of dislocated and stiff elbows .
    • Chronic, persistent joint instability .
    • Acute joint instability after complex ligament injuries .
    • . Unstable elbow fractures
    • Additional stabilization of post-operative unstable internal fixation

    The Elbow Hinge Fixator is compatible with the components of the Synthes Large External Fixator System for adults (rod diameter: Øl 1 mm), and with components of the Synthes Medium External Fixator System (rod diameter: Ø8mm) for children and small stature adults.

    Device Description

    The Synthes External Fixation Devices, MR Conditional consists of previously cleared Medium External Fixation, Distal Radius Fixator, Low-profile Wrist Fixator and Elbow Hinge Fixator devices that are used to construct an external fixation frame.

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria for the "Synthes External Fixation Devices, MR Conditional."

    The document is a 510(k) summary for the device, which focuses on demonstrating substantial equivalence to predicate devices, not on performance studies against specific acceptance criteria.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

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