LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K133402
    Device Name
    K2M MODULAR HOOKS
    Manufacturer
    K2M, INC.
    Date Cleared
    2014-07-30

    (266 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI,OSH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K141147
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    RANGE/DENALI/MESA and SMALL STATURE and ARI are cleared for the following indications:

    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 Range Spinal System may also be used for the same indications as an adjunct to fusion.

    Except for the ARI staples, the Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

    Device Description

    The RANGE / DENALI / MESA Spinal Systems are top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation systems which consists of pedicle screws, rods, hooks and rod connectors.

    The K2M Modular Hook is comprised of a hook body and a variety of adjustable blade options.

    AI/ML Overview

    The provided document describes the acceptance criteria and the study that proves the device meets those criteria for the K2M Modular Hooks, an addition to the RANGE (DENALI/MESA) Spinal System.

    1. Table of acceptance criteria and the reported device performance

    Acceptance Criteria (Test Type)Device Performance (Worst Case K2M Modular Hook)
    Static Compression Bending (ASTM F1717)Demonstrates substantial equivalence to predicate MESA Spinal System performance.
    Dynamic Compression Bending (ASTM F1717)Demonstrates substantial equivalence to predicate MESA Spinal System performance.
    Static A-P (ASTM F1798)Demonstrates substantial equivalence to predicate MESA Spinal System performance.
    Disassembly (ASTM F1798)Demonstrates substantial equivalence to predicate MESA Spinal System performance.

    The document also states that the K2M Modular Hooks have the same technological characteristics (basic design, material, anatomic location, and sizes within the predicate range) as the predicate devices, and any different characteristics (not specified in detail beyond the hook body and adjustable blade options) have been supported by descriptive information and/or performance data demonstrating safety and effectiveness have not been diminished.

    2. Sample size used for the test set and the data provenance:

    • Sample Size: Not explicitly stated as a number. The document mentions "The worst case K2M Modular Hook" was evaluated, suggesting a representative selection rather than a large statistical sample for each test.
    • Data Provenance: Not explicitly stated. The tests are specified as mechanical tests (ASTM F1717, ASTM F1798), implying laboratory testing rather than human subject data. Therefore, country of origin of data, retrospective or prospective, are not applicable in this context.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. This study involves mechanical testing of a medical device (spinal system components), not the assessment or interpretation of medical images or patient data. Ground truth in this context refers to the established mechanical standards (ASTM F1717 and ASTM F1798).

    4. Adjudication method for the test set:

    • Not applicable. This was a mechanical performance study against established ASTM standards, not a clinical or expert-based adjudication process.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • No, an MRMC comparative effectiveness study was not done. This submission is for a spinal implant system component and does not involve AI or human readers.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This submission is for a mechanical spinal implant component.

    7. The type of ground truth used:

    • Mechanical Performance Standards: The ground truth for this study was the established mechanical performance specified by ASTM F1717 (for static and dynamic compression bending) and ASTM F1798 (for static A-P and disassembly tests). The device's performance was compared to that of a legally marketed predicate device (MESA Spinal System) to establish substantial equivalence.

    8. The sample size for the training set:

    • Not applicable. This is a mechanical performance substantial equivalence study, not a machine learning or AI algorithm development study that would involve a training set.

    9. How the ground truth for the training set was established:

    • Not applicable, as there was no training set.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1