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510(k) Data Aggregation

    K Number
    K183618
    Device Name
    Revolution Radial Head
    Manufacturer
    Ignite Orthopedics, Inc.
    Date Cleared
    2019-05-17

    (142 days)

    Product Code
    KWI
    Regulation Number
    888.3170
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ignite Orthopedics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ignite Orthopedics Revolution Radial Head is indicated for: - · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: - o joint destruction and/or subluxation visible on x-ray; and/or - o 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 Revolution Radial Head is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 – 24mm in length. The Revolution Radial Head is manufactured from wrought CoCrMo alloy conforming to ASTM F1537. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
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