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510(k) Data Aggregation

    K Number
    K170061
    Device Name
    ProMIS™ Fixation System
    Manufacturer
    Premia Spine Ltd.
    Date Cleared
    2017-02-02

    (27 days)

    Product Code
    NKB,MNH,MNI
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K150380
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ProMIS™ Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

    The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.

    Device Description

    The ProMIS™ Fixation System consists of 3 main single use implanted parts:

    1. ProMIS™ Fusion Rods: a straight or bent rod with various lengths.
    2. Polyaxial Pedicle screws.
    3. Setscrew.

    All components are manufactured from Ti6Al4V per ASTM F136.

    AI/ML Overview

    This document describes a 510(k) premarket notification for the Premia Spine Ltd.'s ProMIS™ Fixation System, which is a thoracolumbosacral pedicle screw system. The purpose of this 510(k) is to modify the sterilization method of certain rods, add new rod lengths, and introduce a modified set screw and new instrumentation. The document asserts substantial equivalence to a previously cleared device (K150380).

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria / Performance AspectDescription / StandardReported Device Performance
    Sterilization EfficacySterilization validation for gamma irradiation to achieve a Sterility Assurance Level (SAL) of $10^{-6}$.Validated according to ISO 11137-2:2013 by the method of substantiation of 25kGy as a sterilization dose for SAL $10^{-6}$ (VDmax25). This applies to pedicle and set screws, and fusion rods up to 100mm. Fusion rods longer than 100mm are provided non-sterile for steam sterilization by the user.
    PyrogenicityBacterial endotoxin testing (BET) to achieve an Endotoxin limit of to achieve the Endotoxin limit of ), and packaging integrity (ASTM D4169-16, AAMI/ISO 11607-1, ASTM F1980-07).
    • Engineering analysis and functional demonstration: For the mechanical performance of the modified set-screw and the overall system, demonstrating adherence to design specifications and non-deterioration of current worst-case scenarios.

    8. Sample Size for the Training Set

    Not applicable. There is no training set for an AI algorithm in this device submission.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable. There is no training set for an AI algorithm in this device submission.

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