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510(k) Data Aggregation

    K Number
    K192754

    Validate with FDA (Live)

    Device Name
    Avenger Radial Head System
    Manufacturer
    In2Bones USA, LLC
    Date Cleared
    2020-01-07

    (99 days)

    Product Code
    KWI
    Regulation Number
    888.3170
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K060731,K991915,K982288
    Predicate For
    K212872
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Avenger Radial Head System is intended for replacement of the proximal end of the radius:

    • Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at radial-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.

    The components are intended for uncemented use.

    Device Description

    The Avenger Radial Head System is a two-piece modular system comprised of cobalt chrome (ASTM F 1537) head and stem components. The system consists of a range of lengths and diameters for the stem as well as heads in a range of diameters and heights to accommodate the patient anatomy. The stems are offered in short and long lengths. The heads are offered in heights of standard, +2 and +4 configurations. The implant allows for replacement of the radial head.

    AI/ML Overview

    The provided text describes the Avenger Radial Head System, a medical device, and its FDA 510(k) clearance. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding AI/algorithm performance. The document focuses on regulatory clearance based on substantial equivalence to predicate devices and general performance testing (mechanical and biocompatibility).

    Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study evaluating AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or ground truth types related to an AI device.

    The document primarily discusses:

    • Device Name: Avenger Radial Head System
    • Intended Use/Indications for Use: Replacement of the proximal end of the radius for various conditions (degenerative/post-traumatic disabilities, radial head fracture, sequelae after radial head resection, revision of failed arthroplasty). The components are intended for uncemented use.
    • Regulatory Information: Class II device, Regulation Number 21 CFR 888.3170 (Elbow joint radial (hemi elbow) polymer prosthesis), Product Code KWI.
    • Material: Cobalt chrome (ASTM F 1537) for the head and stem components.
    • Substantial Equivalence: Demonstrated to be substantially equivalent to previously cleared devices (Wright Medical Evolve® Modular Radial Head - K060731, K991915; Stryker (SBI/Avanta) Radial Head - K982288) based on similar indications, materials, and geometry.
    • Performance Testing (Mechanical/Biocompatibility):
      • Head disassembly (ASTM F2009)
      • Fatigue testing (ASTM F2887)
      • Bacterial endotoxin testing (LAL)

    No information regarding AI, algorithm performance, or the other specific points requested is available in the provided text.

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