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510(k) Data Aggregation

    K Number
    K203317
    Device Name
    CarboClear X Pedicle Screw System
    Manufacturer
    CarboFix Orthopedics Ltd.
    Date Cleared
    2020-11-25

    (15 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K173487,K182377,K201926,K981676,K130291,K992739,K052398
    Predicate For
    K210716
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CarboClear® X Pedicle Screw System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

    Device Description

    The CarboClear X Pedicle Screw System is composed of implants in various dimensions, used to build a spinal construct; and of a set of instruments, intended to assist in the insertion and placement of the implants.

    The implants include pedicle screws, rods, locking components (a set screw and a nut) and transverse connectors. The implants are made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK). The threaded portion of the pedicle screws is encased within a thin titanium shell, and includes a small tantalum marker.

    The implants are supplied sterile, and are intended for single use.

    AI/ML Overview

    This document is a 510(k) summary for the CarboClear® X Pedicle Screw System, a medical device. It does not present acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria.

    Instead, it provides:

    • Device Name: CarboClear® X Pedicle Screw System
    • Intended Use/Indications for Use: To restore the integrity of the spinal column (even in the absence of fusion for a limited time) in patients with advanced stage thoracic and lumbar spine tumors who have insufficient life expectancy to permit fusion.
    • Regulation Number and Device Class: 21 CFR §888.3070; Class II
    • Product Code: NKB
    • Predicate Devices: CarboClear® Pedicle Screw System (K173487, K182377, K201926) as the primary predicate, and several additional predicate devices from other manufacturers.
    • Performance Data: Static and dynamic tests were performed according to ASTM F1717 and ASTM F1798.
    • Conclusion: The device is substantially equivalent to its predicate devices based on intended use, design, material, dimensions, technological characteristics, and principles of operation, and its performance test results are comparable.

    Therefore, since the provided text relates to a traditional medical device (pedicle screw system) and not an AI/ML powered device, I cannot extract the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device.

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