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510(k) Data Aggregation

    K Number
    K150184

    Validate with FDA (Live)

    Device Name
    Dymaxeon Spine System
    Manufacturer
    Back 2 Basics Direct, LLC
    Date Cleared
    2015-06-15

    (139 days)

    Product Code
    NKB,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K121786,K113058,K080407,K000536,K071373
    Predicate For
    K170989,K180754,K192930
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dymaxeon Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (T1-S1/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, soliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

    Device Description

    The Dymaxeon Spine System is a posterior pedicle screw system manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136) designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of polyaxial pedicle screws and rods. The Dymaxeon Spine System can be used for single or multiple level fixations. The additional Ø5.5mm rod, cannulated screw, transverse connector, and hook components will be used in conjunction with the predicate Dymaxeon Spine System during the fixation of the spine. The components are manufactured from titanium alloy and come in a variety of lengths.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Dymaxeon Spine System, focusing on adding new components to an existing system. The primary goal of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to establish acceptance criteria for an AI/CADe device or to present results from a clinical study comparing device performance against such criteria.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable to this document.

    This document describes a medical device, which is a physical implant, not an AI/CADe system. The preclinical testing mentioned refers to mechanical testing of the physical components, not software performance.

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