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510(k) Data Aggregation

    K Number
    K183197
    Device Name
    PYRAMESH™ Implant System
    Manufacturer
    Medtronic Sofamor Danek USA, INC.
    Date Cleared
    2019-04-04

    (136 days)

    Product Code
    MQP,MOP
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K011406,K091883,K052931,K041389
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PYRAMESH™ implants are for use in the thoracolumbar spine (T1 to L5) to replace and restore the height of a diseased or damaged vertebral body caused by tumor and/or fracture. When used for Spinal Indications PYRAMESH™ implants is intended to be used with supplemental fixation. Allograft material may be used at the surgeon's discretion.

    Device Description

    The PYRAMESH™ implant device is a cylindrically-shaped implantable device with open ends and a hollow core throughout its longitudinal axis. Pyramid shaped openings are built into the wall of the device. These openings and the hollow core allow grafting material to be placed inside the device to help achieve a solid fusion. The contoured ends of the PYRAMESH™ implant serve to grip the superior and inferior end plates when used for spinal indications, thus allowing expulsion resistance.

    The device is made from commercially pure titanium and titanium alloy and is available in various sizes to match patients' anatomical requirements.

    When used as a vertebral body replacement device, the PYRAMESH™ implant is intended to be used with supplemental spinal fixation systems cleared for use in the thoracolumbar spine. The device is not intended to be used as a stand-alone implant.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the PYRAMESH™ Implant System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than outlining the acceptance criteria and performance of an AI/ML-based medical device.

    Therefore, the information required to answer your prompt (acceptance criteria for an AI/ML device, details of a study proving performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training and test sets) is not present in the provided text.

    The document details:

    • Device Description: A cylindrically-shaped implant for vertebral body replacement.
    • Materials: Commercially pure titanium and titanium alloy.
    • Indications for Use: Thoracolumbar spine (T1 to L5) to replace diseased/damaged vertebral bodies due to tumor/fracture, used with supplemental fixation.
    • Predicate Devices: Several previously cleared spinal mesh systems (SPINAL™ Mesh System, T2 Spinal System, VERTE-STACK™ Spinal System, SynMesh System).
    • Performance Data: Biocompatibility testing (in accordance with ASTM standards for titanium materials) and mechanical testing (static expulsion, static compression, static torsion, compression fatigue, and torsion fatigue) and MRI safety/compatibility testing.

    The "Performance Data" section specifically refers to mechanical and biocompatibility testing of the physical implant, and not to the performance of a software algorithm or AI model.

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