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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
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K060731
    Why did this record match?
    Device Name :

    Revolution Radial Head

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    This is a 510(k) premarket notification for the Revolution Radial Head, a medical device for radial head replacement. The provided document is a clearance letter from the FDA, a 510(k) summary, and indications for use. It details the device's characteristics and its substantial equivalence to a predicate device.

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Mechanical StrengthBending stress analysis demonstrated that the strength of the worst-case Revolution Radial Head is greater than the strength of the worst-case predicate device and is adequate for its intended use.
    Endotoxin LevelEndotoxin testing of worst-case samples using the Limulus amebocyte lysate (LAL) method demonstrated an endotoxin level of
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