Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251714

    Validate with FDA (Live)

    Device Name
    Ion-C
    Manufacturer
    Date Cleared
    2026-01-16

    (227 days)

    Product Code
    Regulation Number
    N/A
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ion-C System facet implants are intended to be placed bilaterally through a posterior surgical approach and spans the facet joint interspace. The Ion-C is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. The Ion-C is indicated for patients requiring a revision for an anterior pseudoarthrosis at one or two contiguous levels, from C3 to C7. The Ion-C is only intended to be used in combination with an FDA-cleared anterior cervical plate and intervertebral body fusion device implanted at the same level(s). The Ion-C is intended for use with autogenous and/or allogenic bone graft.

    Device Description

    Ion-C is intended for bilateral stabilization of the facets from C3-C7 at 1- or 2-contiguous levels. Ion-C is intended to be placed bilaterally through a posterior approach and is intended to span the facet joint interspace.

    Ion-C is designed for controlled non-impact placement to minimize damage to the implant and anatomy. Ion-C offers controlled implant depth by allowing in situ depth adjustment. The Ion-C offers a zero profile implant design which includes fenestrations and open barrels allow for bone graft integration and fusion. When Ion-C is implanted the joint is kept in a neutral position, reducing the risk of joint expansion. Ion-C engagement features are designed to resist implant expulsion.

    Ion-C includes various types of Implants, which can be provided sterile or non-sterile. All Implants are manufactured from Ti6Al4V per ASTM F136. The Ion-C Instruments are offered in various configurations, including single-use (provided sterile), and reusable (provided non-sterile). The Ion-C Instruments may be used to rasp or decorticate bone from the facets and/or transverse processes and for the delivery of bone graft.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1