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510(k) Data Aggregation

    K Number
    K132735
    Device Name
    AXIA RADIAL HEAD SYSTEM
    Manufacturer
    IMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME
    Date Cleared
    2014-01-07

    (126 days)

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

    IMDS (INNOVATIVE MEDICAL DEVICE SYSTEMS) - LEIS ME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Radial head arthroplasty The Axia Radial Head System is intended to reduce or relieve pain and restore function and motion to the elbow. - Radial head replacement for degenerative or post-traumatic disabilities when presenting with . pain, crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with: - 0 Joint destruction and/or subluxation - Resistance to conservative treatment O . - Primary radial head replacement after fracture - Symptomatic sequelae after radial head resection ◆ - Revision following failed radial head arthroplasty . CAUTION: This device is intended for uncemented use only.
    Device Description
    The Axia Radial Head System is a 2-part system comprised of a radial head implant and a radial stem implant. There are 6 sizes of radial heads and 6 sizes of stem implant is available in 3 offset sizes. The large combination of implant sizes and the amount size interchangeability in the system allows for better reproduction of individual patient anatomy. The Axia Radial Head System radial head implants are made from cobalt-chromium-molybdenum (Co-Cr-Mo) alloy. The radial head stems are made from titanium alloy (Ti-6Al-4V).
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