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510(k) Data Aggregation

    K Number
    K133103
    Device Name
    AVERSION PEDICLE SCREW SYSTEM
    Manufacturer
    K7 LLC
    Date Cleared
    2014-01-27

    (119 days)

    Product Code
    MNI,MNH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K031655,K041460,K992168,K022623,K950099,K974749,K090648
    Why did this record match?
    Device Name :

    AVERSION PEDICLE SCREW SYSTEM

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

    The Aversion Pedicle Screw System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion

    Device Description

    The Aversion Pedicle Screw System consists of straight and curved rods, polyaxial pedicle screws and crosslink connectors. These are available in a variety of sizes to accommodate differing patient anatomy.

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device called the "Aversion Pedicle Screw System." It is not an AI/ML device, therefore the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC, or standalone performance) related to AI/ML device testing is not applicable.

    The document describes a traditional medical device, a pedicle screw system, and focuses on demonstrating its substantial equivalence to a legally marketed predicate device based on:

    1. Technological characteristics: Basic design (rod-based fixation), material (titanium alloy), anatomic location (non-cervical spine), and sizes.
    2. Performance Data: Mechanical testing (static compression bending and torsion, dynamic compression bending, and pullout testing) performed according to ASTM F1717 and ASTM F543 standards. The results demonstrated substantial equivalence in performance to the predicate devices.

    Therefore, I cannot fulfill the request for information on acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC, or standalone performance as these concepts are specifically relevant to AI/ML device evaluations, which this document does not describe.

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