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510(k) Data Aggregation

    K Number
    K965073
    Device Name
    9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    1997-02-27

    (70 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 9 x 25mm S.I.S. ACL Fixation Screw for Tibial Fixation of Hamstring Tendons Grafts

    Device Description

    The 9 x 25mm S.I.S. ACL Fixation Screw is substantially equivalent to the Arthrex Inc. Cannulated Sheathed Interference Screw, the Concept, Inc. Cannulated Conical Tip Interference Screw, the Depuy Kurosaka Fixation Screw, and the Smith & Nephew RCI ACL Fixation Screw with regard to basic design, intended use, material, and size. The screws are made from implant grade titanium (T16A14V ASTM F136) which is a well know and accepted material for implantable devices. The 9 x 25mm S:I.S. ACL Fixation Screw for Tibial Fixation of Hamstring Tendons Grafts functions the same as the Smith & Nephew RCI ACL Fixation screw for Hamstring Tendons Graft Fixation in the Tibial Tunnel.

    AI/ML Overview

    The provided text is a summary of safety and effectiveness for a medical device, specifically the Smith & Nephew 9 x 25mm S.I.S. ACL Fixation Screw. This document is a 510(k) summary, which is typically submitted to the FDA to demonstrate that a new device is substantially equivalent to a predicate device already on the market.

    Crucially, this document does not contain information about acceptance criteria or a study demonstrating the device meets those criteria (in the sense of a performance study with metrics like sensitivity, specificity, etc.).

    Instead, it focuses on demonstrating substantial equivalence based on:

    • Design: Similar to predicate devices.
    • Intended Use: Similar to predicate devices.
    • Material: Implant grade titanium (T16A14V ASTM F136), a well-known and accepted material.
    • Size: Similar to predicate devices.
    • Function: Functions the same as a previously cleared Smith & Nephew RCI ACL Fixation screw for Hamstring Tendons Graft Fixation in the Tibial Tunnel.

    Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The document is about regulatory clearance based on equivalence, not a performance study against specific acceptance criteria.

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