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510(k) Data Aggregation

    K Number
    K221905
    Device Name
    INERTIA CONNEXX Modular Pedicle Screw System
    Manufacturer
    Nexxt Spine LLC
    Date Cleared
    2022-07-28

    (28 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K153453,K143334,K152457,K090984,K101278,K132412,K141376
    Why did this record match?
    Device Name :

    INERTIA CONNEXX Modular Pedicle Screw System

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

    The INERTIA® CONNEXX™ Modular Pedicle Screw System is intended for immobilization and stabilization of the posterior non-cervical spine (TI-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease ( 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, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

    When used for posterior non-cervical pedicle screw fixation in pediative patients, the INERTIA® CONNEXX™ Modular Pedicle Screw System implants are indicated as an adjunct to treat adolescent idiopathic scolosis. The INERTIA® CONNEXX™ Modular Pedicle Screw System is to be used with autograft and/or allografi. Pediatric pediatic pediatic pediatic pediatic pediatic pediatic pedicle screw fixation is limited to a posterior approach.

    Device Description

    The INERTIA® CONNEXX™ Modular Pedicle Screw System consists of longitudinal members (rods), anchors (pedicle screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The INERTIA® CONNEXX™ Modular Pedicle Screw System implants are sold sterile and non-sterile.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for the INERTIA® CONNEXX™ Modular Pedicle Screw System. This document outlines the device's indications for use, description, and the performance data submitted to demonstrate substantial equivalence to legally marketed predicate devices.

    However, the provided text does not contain any information about a study proving that an AI/ML device meets acceptance criteria. The entire document pertains to a physical medical device (pedicle screw system) and focuses on mechanical testing for substantial equivalence, not on the performance of a software or AI/ML product.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI/ML device meets them based on the provided input. The input text is for a different type of medical device entirely.

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