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    K Number
    K162874
    Device Name
    Cannulated Screws Neoortho
    Manufacturer
    Neoortho Produtos Ortopedicos S/A
    Date Cleared
    2017-06-27

    (257 days)

    Product Code
    HWC,HTN
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K142057,K050636
    Why did this record match?
    Reference Devices :

    K142057,K050636

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

    The Cannulated Screws Neoortho are generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, metatarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. The Cannulated Screws Neoortho are also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections. Accessories implants: The washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.

    Device Description

    The Neoortho Cannulated Screws include nine cannulated screw specifications and associated washers, which are manufactured from stainless steel and titanium alloy. The cannulated screw is a self-tapping screw with a cancellous or cortical thread that can be guided into a position via a guided wire. They are used to aid in the alignment and stabilization of fractures to the skeletal system.

    The technological characteristic of the Neoortho Cannulated Screws are similar to the predicate devices including design, dimensions, and materials. The Neoortho cannulated screws and washers are fabricated from stainless steel per ASTM F138 and Ti-6Al-4V alloy per ASTM F136. The stainless steel and Ti-6Al-4V are commonly used material in orthopedic implants.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for "Cannulated Screws Neoortho" and details the non-clinical tests performed to demonstrate substantial equivalence to predicate devices. It does not contain information about an AI device or details relating to acceptance criteria and studies typically associated with AI/ML medical devices. The document focuses on mechanical and sterilization properties for an orthopedic implant.

    Therefore, I cannot provide an answer based on the prompt's request for AI device acceptance criteria, performance, and study details like sample size for test/training sets, expert qualifications, or MRMC studies.

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