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    K Number
    K232173
    Device Name
    Ascend VBR System, Ascend NanoTec VBR System
    Manufacturer
    Alphatec Spine, Inc.
    Date Cleared
    2023-10-06

    (77 days)

    Product Code
    MQP,PLR
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K222028,K180480,K211805,K161363,K192938,K222973,K192117,K050553,K193506
    Why did this record match?
    Reference Devices :

    K222028, K180480, K211805, K161363, K192938, K222973

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

    The Ascend VBR System is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

    The Ascend VBR System is also 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 cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

    The Ascend VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend VBR System is optional.

    The Ascend NanoTec VBR System with advanced NanoTec surface treatment is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

    The Ascend NanoTec VBR System is also 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 cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

    The Ascend NanoTec VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend NanoTec VBR System is optional.

    Device Description

    The Ascend VBR Systems are cervical and thoracolumbar vertebral body replacement systems designed to be inserted in the anterior, anterolateral, and posterior approaches. The implants consist of VBR cores and endplates offered in a range of diameters and heights, endplates, footprints, and lordotic angles to accommodate individual patient anatomy.

    The cores are made of titanium alloy per ASTM F136 and the endplates are made of titanium alloy per ASTM F136 or are made of hybrid titanium consisting of commercially pure porous titanium CP-Ti Grade 2 per ASTM F67 and titanium alloy per ASTM F136.

    The modular endplates are offered with an optional 20-40 nanometer thin hydroxyapatite surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device – the Ascend™ VBR System and Ascend™ NanoTec™ VBR System, which are vertebral body replacement devices. The content focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for FDA clearance.

    The provided text does not contain any information about an AI/ML-based device or its performance criteria. The entire document pertains to physical medical devices (spinal implants) and their mechanical, chemical, and biological performance characteristics.

    Therefore, it is not possible to describe acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided input. The document details traditional medical device testing, such as:

    • Static and Dynamic Axial Compression per ASTM F2077
    • Static and Dynamic Torsion per ASTM F2077
    • Static Subsidence per ASTM F2267
    • Static Push-out
    • Gravimetric Analysis per ASTM F1714
    • Particulate Analysis per ASTM F1877
    • Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2019
    • Biocompatibility Testing per ISO 10993-1

    These tests are standard for evaluating the mechanical and biocompatibility properties of physical implants, not the performance of an AI/ML algorithm.

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