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510(k) Data Aggregation

    K Number
    K161904
    Device Name
    GEO Bone Screw System
    Manufacturer
    GRAMERCY EXTREMITY ORTHOPEIDICS, LLC
    Date Cleared
    2017-01-18

    (191 days)

    Product Code
    HWC,HTN
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K042310,K143460,K150693
    Why did this record match?
    Applicant Name (Manufacturer) :

    GRAMERCY EXTREMITY ORTHOPEIDICS, LLC

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

    The GEO Bone Screw System is indicated for bone fractures, arthrodesis, osteochondritis, and tendon reattachment.

    Device Description

    The GEO Bone Screw System implants include cannulated and solid, low-profile headed and headless, partial and fully threaded bone screws in a variety of diameters and lengths. Optional washers, correspondingly sized to each bone screw, are available as well as k-wires and general orthopedic instruments. GEO implants are comprised of titanium alloy. The GEO Bone Screw System is provided sterile by exposure to gamma irradiation.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device called the "GEO Bone Screw System." It does not contain information about an AI/ML powered device or study results related to AI/ML. Therefore, I cannot extract the requested information about acceptance criteria and study data for an AI/ML device.

    The provided text describes a bone screw system, its indications for use, and a comparison to predicate devices, focusing on technical characteristics and mechanical performance (torsional strength, pullout strength, pyrogenicity). It explicitly states: "No clinical performance data were needed to support substantial equivalence." This means it relied on engineering analysis and comparison to existing devices, not clinical trials or AI/ML performance evaluations.

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