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510(k) Data Aggregation

    K Number
    K031290
    Device Name
    MODIFICATION TO EASYS TRANSVERSE CONNECTION
    Manufacturer
    SCIENT'X USA, INC.
    Date Cleared
    2003-05-13

    (20 days)

    Product Code
    MNH,KWP,MNI
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K013447,K020245,K013444,K013440,K990118
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EASYS Transverse Connection used with the ISOBAR Spinal System is intended for posterior, nonpedicle screw fixation of the noncervical spine/hook and sacral/iliac screw fixation to the noncervical spine/hook and sacral screw fixation to the T1-S1 spine.

    Indications for use include:

    • 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
    • deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
    • tumor
    • pseudoarthrosis
    • failed previous fusion

    The ISOBAR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 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.

    The ISOBAR Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal tumor, and failed previous fusion (pseudarthrosis).

    Device Description

    The ISOBAR Spine System is a pedicle screw system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar or sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusions.

    As a pedicle screw system the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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.

    The ISOBAR Spinal System consists of monoaxial and polyaxial pedicle screws (K990118, K013447 and K020245) rods, nuts and cross link members. It can be used for single or multiple level fixation. It also included single and double hooks (K013444 and K013440) used for posterior, nonpedicle screw fixation of the noncervical spine/hook and sacral/illiac screw fixation to the noncervical spine/hook and sacral screw fixation to the T1-S1 spine.

    All components are manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136.

    The additional component that is the subject of this Special 510(k) submission is the EASYS Transverse Connection. Its purpose is to provide rigidity to the spinal construct similar to the crosslink cleared on K990118. It consists of a cross bar and two self locking jumper consists of a clamp and tightening screw.

    AI/ML Overview

    The EASYS Transverse Connection is a component intended to provide rigidity to a spinal construct, similar to a previously cleared crosslink for the ISOBAR Spinal System.

    The device's acceptance criteria and the study proving it meets these criteria are described as follows:

    1. Table of Acceptance Criteria and Reported Device Performance:
    Acceptance CriteriaReported Device Performance
    Equivalent or superior strength to predicate device crosslink."Tcsting per ASTM 1717 found that the EASYS Transverse Connection is as strong as the predicate device." Therefore, it meets the acceptance criteria of being as strong as the predicate device.

    1. Sample size used for the test set and the data provenance: Not applicable. The study involved a comparison of mechanical properties, not a clinical test set.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The study was a non-clinical mechanical test.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The study was a non-clinical mechanical test.

    4. 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: Not applicable. This is a mechanical device, not an AI or imaging device requiring human reader studies.

    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.

    6. The type of ground truth used: The ground truth was based on the mechanical strength of the predicate device's crosslink as measured by ASTM 1717.

    7. The sample size for the training set: Not applicable. This is a non-clinical mechanical test, not a machine learning study with a training set.

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

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