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510(k) Data Aggregation

    K Number
    K203125
    Device Name
    Invictus™ OCT Spinal Fixation System
    Manufacturer
    Alphatec Spine, Inc.
    Date Cleared
    2020-12-18

    (60 days)

    Product Code
    NKG
    Regulation Number
    888.3075
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K191185,K200936,K153631,K161032,K111076,K093319,K200130,K161363,K192938
    Why did this record match?
    Device Name :

    Invictus™ OCT Spinal Fixation System

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

    The Invictus™ OCT Spinal Fixation System is intended to provide immobilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniccervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g.,pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Invictus OCT Spinal 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 advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

    In order to achieve additional levels of fixation, the Invictus OCT Spinal Fixation System may be connected to the components in the Arsenal® Spinal Fixation System or the Invictus™ System offered by Alphates Spine using various rod-to-rod connectors and/or transitional rods.

    Device Description

    The purpose of this submission is to add occipital components to the previously cleared Invictus™ CT Spinal Fixation System (K200936). The Invictus™ OCT Spinal Fixation System is a posterior approach system designed to stabilize the cervico-thoracic spine and/or occiput with or without fusion. The Invictus OCT system is intended to be compatible with Arsenal® Spinal Fixation System or the Invictus™ Spinal Fixation System offered by Alphatec Spine using various rod-to-rod connectors and/or transitional rods.

    The Invictus OCT implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and cobalt chromium (Co-28Cr-6Mo) alloy per ASTM F1537. The Invictus OCT System consists of a variety of shapes and sizes of plates, screws, rods, cross connectors, rod-to-rod connectors and general surgical instruments that provide internal fixation and stabilization during bone graft healing and/or fusion mass development.

    The Invictus OCT implants are provided non-sterile to be steam sterilized by the end user. The instruments are made of stainless steel and other materials, and are provided nonsterile to be cleaned and sterilized by the end user.

    AI/ML Overview

    This is not a medical device that uses AI. This is a spinal fixation system. As such, information regarding acceptance criteria, study details, and AI-specific performance metrics (like sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for AI) are not applicable or found in the provided document.

    The document discusses the regulatory review of a physical medical device. It confirms the device, the Invictus™ OCT Spinal Fixation System, is substantially equivalent to legally marketed predicate devices based on its intended use, indications for use, design, technology, and nonclinical performance data.

    Here's the relevant information that is provided:

    1. Acceptance Criteria and Reported Device Performance (Nonclinical Testing):

    Acceptance Criteria (Test Standard)Reported Device Performance (Supports Substantial Equivalence)
    Static and dynamic compression bending per ASTM F2706Results demonstrate substantial equivalence to predicate devices.
    Static and dynamic torsion per ASTM F2706Results demonstrate substantial equivalence to predicate devices.
    Static flexion-extension moment per ASTM F1798Results demonstrate substantial equivalence to predicate devices.

    2. Sample size used for the test set and the data provenance: Not applicable for this type of nonclinical, physical device testing. The "test set" would refer to the physical devices themselves and the conditions under which they were tested according to ASTM standards.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device mechanical testing is based on established engineering standards and measurements, not expert consensus on diagnostic images.

    4. Adjudication method for the test set: Not applicable for this type of nonclinical testing.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This device is not an AI-powered diagnostic or assistive tool for human readers.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical spinal fixation system, not an algorithm.

    7. The type of ground truth used: For the nonclinical performance data, the "ground truth" is defined by the objective physical measurements and engineering criteria outlined in the ASTM standards (F2706 and F1798).

    8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

    9. How the ground truth for the training set was established: Not applicable.

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