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510(k) Data Aggregation

    K Number
    K102601
    Device Name
    ORTHOFLEX ROD
    Manufacturer
    ORTHO-PRO LLC
    Date Cleared
    2011-01-14

    (127 days)

    Product Code
    KWH
    Regulation Number
    888.3720
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K905795,K801094
    Predicate For
    K190136
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The indications for the OrthoFlex Rod include:

    • Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis
    • Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis
    • Revision of a failed arthroplasty or arthrodesis
    Device Description

    The OrthoFlex Rod design is a double-stemmed flexible implant designed for the proximal interphalangeal joint of the lateral toes. It is made of silicone elastomer, and is constructed in a rod-shaped design with a thicker mid-section spacer or collar.

    AI/ML Overview

    This OrthoFlex Rod 510(k) summary explicitly states that "No clinical studies were performed" and therefore no acceptance criteria or studies proving device performance against such criteria are provided in the document.

    The submission focuses on establishing substantial equivalence to predicate devices based on intended use, design, material, and function, rather than demonstrating performance through clinical studies and predefined acceptance criteria.

    Therefore, the requested tables and information cannot be generated from the given text.

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