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510(k) Data Aggregation

    K Number
    K233089
    Device Name
    NeoSpan® Compression Implant System
    Manufacturer
    In2Bones USA, LLC
    Date Cleared
    2024-05-24

    (241 days)

    Product Code
    HRS,HWC,JDR
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K201149,K181113,K161426,K160300,K222645,K112837
    Why did this record match?
    Device Name :

    NeoSpan**®** Compression Implant System

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

    The NeoSpan® Compression Implant System is a nitinol implant intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.

    Device Description

    In2Bones NeoSpan® Compression Implant System (CIS) is a product expansion of the existing NeoSpan Compression Staple Implant w/ Instruments (K161426). The NeoSpan® Compression Implant System consists of implants offered in various configurations from 2 and 3 legs with no hole or 1-to-3 holes intended for bone screw assembly for additional fixation. The fixed-leg implants are comprised of Nitinol per ASTM F2063. The devices are sterile implants intended to provide fixation of fractures, fusions, or osteotomies of the hand and foot.

    Bone screw options for the NeoSpan® Compression Implant System are previously cleared 3.0mm and 3.5mm locking and non-locking screws in lengths 10-30mm made from titanium alloy.

    AI/ML Overview

    The provided text is a 510(k) summary for the NeoSpan® Compression Implant System, describing a medical device used for bone fixation. It does NOT contain any information about a study proving the device meets acceptance criteria for an AI/software-based medical device.

    The document primarily focuses on demonstrating substantial equivalence of the physical implant system to previously cleared predicate devices through performance testing related to mechanical properties (e.g., static bending, fatigue bending, pull-out, corrosion) and biological/sterilization properties, not performance of an AI algorithm.

    Therefore, I cannot provide the requested information about acceptance criteria for an AI device or a study proving an AI device meets those criteria, as the input document is about an implantable hardware device.

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