LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K142360
    Device Name
    Everest Spinal System
    Manufacturer
    K2M, Inc
    Date Cleared
    2015-01-21

    (149 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI,OSH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K140529,K132328
    Predicate For
    K151216,K151727,K173508
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications:

    Posterior non-cervical fixation 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

    Except for hooks, when used as an anterolateral thoracic/lumbar system the Everest Spinal System may also be used for the same indications as an adjunct to fusion.

    When used for posterior non-cervical pedicle screw fixation in pediatric patients the Everest Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

    Device Description

    The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation system which consists of pedicle screws, rods, hooks and rod connectors.

    Materials: The proposed implants are manufactured from Titanium per ASTM standards.

    Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

    Purpose of Submission: Additional connectors

    AI/ML Overview

    This document is a 510(k) premarket notification for the Everest Spinal System. It does not describe a study to prove device performance against acceptance criteria for an AI/software device. Instead, it demonstrates substantial equivalence to predicate devices through mechanical testing for a physical implantable device.

    Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI system based on the provided text.

    The document discusses:

    • Device Name: Everest Spinal System
    • Submission Type: 510(k) premarket notification for "Additional Connectors" for an existing spinal system.
    • Device Type: Pedicle screw spinal system (physical implant).
    • Predicate Devices: Everest Spinal System (K140529) and Medtronic CD Horizon (K132328).
    • Testing: Mechanical testing performed in accordance with ASTM F1798 and ASTM F1717 (static torsion, static compression, and dynamic compression bending).
    • Conclusion: The device was found substantially equivalent to predicate devices, and the proposed implants do not represent a new worst case.

    None of the information requested in points 1-9 (e.g., acceptance criteria for AI, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is applicable or present in this document, as it pertains to a different type of medical device (hardware vs. software/AI).

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1