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510(k) Data Aggregation

    K Number
    K130954
    Device Name
    ARS SCREW; SLANT SCREW
    Manufacturer
    ADVANCED INTERVENTIONAL TECHNOLOGY, LLC
    Date Cleared
    2013-05-31

    (56 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K071639,K050346
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ARS and SLANT SCREW medical devices are indicated for the fixation of bone fractures and bone reconstruction. Examples include but are not limited to:
    · Fixation of bone fragments in long or small bone fractures
    · arthrodesis in hand or foot surgery
    · mono or bi-cortical osteotomies in the foot or hand
    · distal or proximal metatarsal or metacarpal osteotomies
    · fixation of osteotomies for hallux valgus treatment (such as Scarf, Chevron, etc.)

    Device Description

    The ARS and SLANT Screws are made of titanium alloy (Ti6A14V) according to ISO 5832-3 and ASTM F 136. They are self-drilling, self-tapping and designed with a double thread for better grip on tissue. The ARS and SLANT Screws are intended for single use only.
    The titanium ARS and SLANT SCREWs are cannulated for use with a guide wire and have double-threading and different pitch for the proximal and distal threads. The headless screws can be completely embedded in the bone thus avoiding any protrusion that could cause irritation to the tissue. The double-thread design assures compression and stability of the fractures. Both screws have reverse-cutting flutes in the head threaded portion to facilitate removal of the screw.
    The code to clearly identify each product is laser-marked on the unthreaded cylindrical screw part. The screws are color coded (anodized) to be easily recognized ARS (blue) from SLANT (green).

    AI/ML Overview

    The provided text is related to a 510(k) submission for bone fixation screws, not an AI/ML powered medical device. Therefore, it does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), ground truth establishment, sample sizes for training/test sets, expert qualifications, or details of a comparative effectiveness study that would be relevant to an AI/ML device.

    The document is a traditional medical device submission for orthopedic screws and focuses on demonstrating substantial equivalence to predicate devices based on material, design, and indications for use.

    Therefore, I cannot fulfill the request as the provided input does not describe an AI/ML powered medical device.

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