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510(k) Data Aggregation

    K Number
    K061621
    Device Name
    SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2006-07-27

    (45 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Synthes (USA) 6.5 mm Cancellous Screws are intended for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.

    Device Description

    The Synthes (USA) 6.5 mm Cancellous Screws incorporate a fully threaded shaft, 4.0 mm core diameter, and have a flat head profile with rounded edges. They are available in lengths ranging from 60 mm to 130 mm in both Stainless Steel and Titanium Alloy. The screws are provided STERILE and NON STERILE.

    AI/ML Overview

    The provided text is a 510(k) summary for the Synthes (USA) 6.5 mm Cancellous Screws. It describes the device, its intended use, and its classification and predicate devices. However, this document does not contain information regarding acceptance criteria, device performance studies, sample sizes for testing or training, expert ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).

    The document is a regulatory submission demonstrating substantial equivalence to previously marketed devices, not a scientific study reporting performance metrics against acceptance criteria. Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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