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510(k) Data Aggregation

    K Number
    K193472
    Device Name
    OrthoCircle Spine Pedicle Screw System
    Manufacturer
    OrthoCircle Spine
    Date Cleared
    2020-02-13

    (59 days)

    Product Code
    NKB,KWQ
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K171170,K191576
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OrthoCircle Spine Pedicle Screw System is a thoracolumbosacral (T1-S1) spinal fixation system containing devices intended for use as a posterior pedicle screw fixation system. Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all the following indications: degenerative disc disease (defined as discogenic back pain 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, and/or failed previous fusion (pseudoarthrosis).

    Device Description

    The OrthoCircle Spine Pedicle Screw System is a titanium alloy implant device to be implanted from the posterior approach. The system consists of rods, poly-axial screws and set screws. The screws are available in diameters from Ø4.50mm to Ø7.50mm and in lengths of 20mm to 60mm. Standard and Reduction Pedicle Screws are available in these sizes. Titanium rods are available in Ø5.50mm diameter straight and pre-contoured. Set screws are used to fasten the rods and poly-axial screws. Implants are provided sterile in individual packaging.

    Special instruments are used to implant the pedicle system. Instruments used to implant the pedicle screw system are provided as non-sterilization prior to use.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria.

    The document is a 510(k) summary for the OrthoCircle Spine Pedicle Screw System, focusing on demonstrating substantial equivalence to predicate devices based on indications for use, materials, structural support, sizes, and specific mechanical performance tests (static compression bending, static torsion, and dynamic compression bending per ASTM F1717-18).

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance using the provided text.

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