CoFix™ implant
    A secure fixation system supporting spinal fusion.

    The CoFix™ implant is a titanium device that stabilizes the spine as an adjunct to lumbar fusion.
    Its wing and screw design provides secure fixation to support natural healing.

    NOTE: The CoFix™ implant is available in the United States as an FDA 510k-approved Device.

    Intended Purpose

    🇺🇸 US

    The CoFix™ implant is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1–S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies – with up to Grade 1 spondylolisthesis.

    🇪🇺 EUROPEAN UNION

    The CoFix™ implant is a posterior, non-pedicle supplemental fixation device intended for permanent implantation as an adjunct to different fusion techniques in the lumbar spine (L1–S1) in one level. Each wing of the CoFix™ interlaminar implant is attached to the spinous process with the use of a CoFix™ screw/sleeve. It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in the following conditions: instability, including degenerative disc disease – defined as back pain of discogenic origin with degeneration of the disc, facet joints and pseudospondylolisthesis up to Meyerding grade I, confirmed by history and radiographic studies.

    The CoFix™ implant is designed to be used in patients with adequate facet joints as defined by a minimum of 50% of the medial facet and all facet capsules after the implantation of the CoFix™ implant.

    The CoFix™ implant provides additional segmental stabilization to increase the segmental stiffness and promote the fusion process. The CoFix™ implant is not intended for stand-alone use.

     

    Implantation Parameters

    Please refer to the applicable regional Instructions for Use (IFU), indications, contraindications, and regulatory approvals relevant to your country or market prior to use, as device indications and requirements may vary by jurisdiction.

    For more information about CoFix™, visit : 

    CoFix™ page