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510(k) Data Aggregation

    K Number
    K030384
    Device Name
    EVOLVE CERAMIC RADIAL HEAD IMPLANT
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2003-08-12

    (188 days)

    Product Code
    KWI
    Regulation Number
    888.3170
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K991915,K960659
    Why did this record match?
    Reference Devices :

    K991915,K960659

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

    Use of the Modular Radial Head Implant may be considered for :

    • . Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
      • a. joint destruction and/or subluxation visible on x-ray; and/or
      • b. resistance to conservative treatment.
    • Primary replacement after fracture of the radial head.
    • Symptomatic sequelae after radial head resection. .
    • Revision following failed radial head arthroplasty. ●
    Device Description

    The EVOLVE® Ceramic Radial Head Implant is identical to the head component previously submitted and cleared under 510(k): K991915- EVOLVE® Modular Radial Head. The only difference between the two devices is the type of materials used to manufacture the head components. The EVOLVE® Modular Radial Head system is approved with a CoCr head component, and a CoCr stem component. Wright Medical Technology is now adding a ceramic head component for use with the CoCr stem component previously cleared under the EVOLVE® Modular Radial Head (510(k): K991915).

    The design features for both EVOLVE® radial head components are as follows:

    • The proximal portion of the radial head will have a concave design to provide . stability to the bearing surface and closely approximate the natural anatomy of the radial head and humeral-capitellum articulating surface.
    • The sides of the head are designed with a radius of curvature that articulates with the . proximal radial-ulnar joint and closely approximates the natural anatomy.
    • The heads are interchangeable, since the interface has the same dimensions ● throughout the system.
    • Heads are available in 2.0mm increments, ranging from 20.0mm to 28.0mm in . diameter.
    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device (EVOLVE® Ceramic Radial Head Implant), focusing on its substantial equivalence to previously cleared devices.

    Therefore, I cannot extract the requested information.

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