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510(k) Data Aggregation

    K Number
    K231447
    Device Name
    Double Internal Joint Stabilizer- Elbow
    Manufacturer
    Skeletal Dynamics Inc
    Date Cleared
    2023-12-15

    (211 days)

    Product Code
    OZI,LXT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K223318,K153208
    Why did this record match?
    Reference Devices :

    K223318

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

    The Double Internal Joint Stabilizer - Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.

    Device Description

    The Predicate Internal Joint Stabilizer - Elbow (IJS-E) System consists of a titanium base plate, with the following components: A Distal Connecting Rod and Proximal Connecting Rod, held together by adjustable locking joints and locking screws which allow for multiple degrees of freedom. The Proximal Connecting Rod is secured to the distal humerus at the axis of rotation using a cobalt chrome axis pin provided in multiple lengths from 30mm to 70mm in 5mm increments.

    The subject Double Internal Joint Stabilizer - Elbow (IJS-E) System is modifying the predicate IJS-E Base Plate to add an additional set of components to the other side of the IJS-E Base plate. The Proximal Connecting Rods from each side of the Double IJS-E base plate are secured to the distal humerus at the axis of rotation using the predicate male axis pin from one side and the new female axis pin from the other side. The male axis pin telescopes within the female axis pin within the distal humerus.

    The subject Double Internal Joint Stabilizer - Elbow Base Plate is attached to the Ulna by the same 3.5mm compression screws as the predicate IJS-E system (K153208). The modified system provides internal stabilization to the elbow joint in the same manner, function, and technology as the Company's cleared Internal Joint Stabilizer - Elbow. The system includes specialized instrumentation.

    The system is provided non-sterile and is sterilized in the user facility.

    AI/ML Overview

    The provided text does not contain information about an AI/ML medical device, its acceptance criteria, or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a non-AI medical device, the "Double Internal Joint Stabilizer- Elbow."

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text lacks the necessary information.

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