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510(k) Data Aggregation

    K Number
    K112037
    Device Name
    RANGE SPINAL SYSTEM (MESA AND DENALI)
    Manufacturer
    K2M, INC.
    Date Cleared
    2011-10-06

    (80 days)

    Product Code
    MNI,KWP,MNH
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K070229,K080792,K081381,K052398,K080611,K042635,K061520
    Predicate For
    K120099,K120656,K120899,K121016,K131030,K132361,K140529
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Range Spinal System is comprised of the DENALI, DENALI DEFORMITY, and MESA Spinal Systems and the ARI Anterior Vertebral Body Staples, all of which are cleared for the following indications:

    Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to firstien for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

    Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (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 tordosis); tumor; pseudoarthrosis; and failed previous fusion.

    Device Description

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

    AI/ML Overview

    Here's the analysis of the provided text regarding the Range Spinal System:

    This document is a 510(k) summary for component modifications to an existing device, the Range Spinal System. It does not describe a clinical study in the traditional sense, but rather a mechanical testing comparison to establish substantial equivalence with predicate devices. Therefore, many of the requested categories related to clinical studies and expert review will not be applicable.

    Acceptance Criteria and Study Details

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    Mechanical PerformanceThe modified components of the Range Spinal System must perform equally to or better than the predicate devices in static compression, static torsion, and dynamic compression. This testing is to be conducted in accordance with ASTM F1717. (This is inferred from "The modifications to the Range Spinal System were mechanically tested and compared to predicate devices. The modified component performed equally to or better than these systems in static compression, static torsion and dynamic compression in accordance with ASTM F1717.")The modified component performed equally to or better than the predicate systems in static compression, static torsion, and dynamic compression.
    Substantial EquivalenceDesign Features: Similar to predicate devices. (Inferred from "The design features and sizing of the components were compared to predicate devices and the Range Spinal System was found to be substantially the same as these systems.") Function: Similar to predicate devices. (Inferred from "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.") Material: Similar to predicate devices. (Inferred from "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.") Intended Use: Similar to predicate devices. (Inferred from "There are no significant differences between the Range Spinal Systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.")The Range Spinal System's design features and sizing were found to be substantially the same as predicate systems. The device maintains substantial equivalence to other devices in design, function, material, and intended use. There are no significant differences that would adversely affect product use.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not applicable. This was a mechanical engineering test on components, not a clinical study on human subjects or clinical data. The "sample" would be the number of test articles (modified components) subjected to mechanical loads, which is not specified but would follow ASTM F1717 guidelines.
    • Data Provenance: Not applicable in terms of country of origin or retrospective/prospective. The data comes from mechanical laboratory testing of device components.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

    • Not applicable. Ground truth for mechanical performance tests is established by adhering to standardized testing protocols (e.g., ASTM F1717) and engineering measurements, not by expert clinical consensus.

    4. Adjudication Method for the Test Set

    • Not applicable. This was a mechanical test, not a subjective assessment requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • Not applicable. This is not a clinical study involving human readers or assessment of AI performance.

    6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

    • Not applicable. This is not an AI/algorithm-based device.

    7. Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

    • Ground Truth: For mechanical testing, the "ground truth" is defined by the objective, quantifiable measurements of force, displacement, cycles to failure, and other mechanical properties obtained through standardized testing methods (ASTM F1717). The performance of the predicate devices under these same conditions serves as the benchmark.

    8. Sample Size for the Training Set

    • Not applicable. This is not an AI/machine learning device that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable. This is not an AI/machine learning device.
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