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510(k) Data Aggregation

    K Number
    K203100
    Device Name
    Arthrex Eclipse Titanium Humeral Head
    Manufacturer
    Arthrex Inc.
    Date Cleared
    2020-11-20

    (37 days)

    Product Code
    PKC,QHQ
    Regulation Number
    888.3660
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K182799,K183194,K201542
    Why did this record match?
    Device Name :

    Arthrex Eclipse Titanium Humeral Head

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

    The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis. The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.

    The Arthrex Eclipse Titanium Humeral Head is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

    Device Description

    The proposed Eclipse Titanium humeral head is manufactured from Ti-6Al-4V ELI per ASTM F136 and is offered in sizes ranging from 37-55mm with varying offsets of 16-23mm. The humeral head is placed on a trunnion, which is fixated to the proximal humerus by a hollow screw. The Titanium humeral heads are used with the existing trunnions and hollow screws cleared under the predicate.

    AI/ML Overview

    This FDA 510(k) summary describes a medical device, the Arthrex Eclipse Titanium Humeral Head, which is a shoulder prosthesis. However, it does not contain information about the acceptance criteria and study proving a software or AI-based device's performance.

    The document pertains to a physical orthopedic implant. The "Performance Data" section discusses:

    • Fatigue testing and Pull Off testing: Evaluates the mechanical properties of the humeral head.
    • Engineering analysis: Compares hardness, adhesion, surface roughness, scratch resistance, and Young's modulus to the predicate device.
    • Bacterial endotoxin testing: Ensures pyrogen limits are met.
    • MRI compatibility engineering analysis: Addresses MRI force, torque, and image artifact.

    These are all standard tests for physical medical implants and not for software or AI performance. Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving the device (as in, a software or AI device) meets critical performance measures from the provided text.

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