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510(k) Data Aggregation

    K Number
    K051678
    Manufacturer
    Date Cleared
    2005-09-21

    (90 days)

    Product Code
    Regulation Number
    888.3020
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM

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

    The Synthes Hindfoot Arthrodesis Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include, but are not limited to Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.

    Device Description

    Synthes Hindfoot Arthrodesis Nail System is composed of titanium cannulated arthrodesis nails, 6.0 mm Locking Screws, and end caps. Synthes commercially available spiral blades, locking screws, and locking bolts are used to secure the nail in the bone, preventing rotation and axial compression.

    AI/ML Overview

    I am sorry, but I am unable to answer your question. The provided text is a 510(k) summary for a medical device (Synthes Hindfoot Arthrodesis Nail System) and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This document is a regulatory submission demonstrating substantial equivalence to predicate devices, not a study report detailing specific performance metrics or clinical trial results. Therefore, I cannot extract the requested information from the given context.

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