The CoFix™ implant is a spinous process fixation device that stabilizes the spinous processes and spine to act as an adjunct to fusion. The CoFix™ interlaminar implant has two sets of wings. A screw & sleeve are inserted through the holes in the wing and through a prepared hole in the spinous process to fix the crimped wings to the superior and inferior spinous processes.
Intended Purpose
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
It is intended for application at all levels of the lumbar spine (L1–S1) in cases of back pain and discogenic pain due to lumbar degenerative processes, such as pseudospondylolisthesis (up to Meyerding grade I), osteochondrosis, instability of facet joints, lumbar stenosis, or lumbar disc prolapses.
Material
The CoFix™ implant is made from wrought titanium 6-aluminum 4-vanadium alloy (ISO 5832-3).
It is supplied sterile and is available in numerous sizes.
Surgical Technique Guide
Please access the current Surgical Technique Manuals for detailed step-by-step guidance on the proper handling and implantation of our devices. These manuals are intended for trained medical professionals only. The CoFix™ implant is intended to be used exclusively in combination with the designated CoFix™ instruments. The correct and safe use of the implant is ensured only when the associated surgical instruments specified for the CoFix™ system are utilized. The complete list and description of these designated instruments are provided in the CoFix™ Surgical Technique Guide (RQM00009 Rev. A). This guide outlines the appropriate surgical steps, instrumentation, and procedures necessary for safe and effective implantation and removal.
The Surgical Technique Guide (RQM00009 Rev. A) is available below :
Summary of Safety and Performance (SSCP)
In accordance with the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745), access to the Summary of Safety and Clinical Performance (SSCP) is provided for applicable devices. The SSCP is intended to give healthcare professionals and, where relevant, patients clear, updated information on the safety, clinical benefits, and performance of the device. The document can be requested by contacting our Customer Service department.Please contact us at psg-service@paradigmspine.com for additional details or support.
Implant Cards
In line with EU MDR (Regulation (EU) 2017/745) requirements, all Paradigm Spine implants are supplied with an Implant Card for patients. Please ensure that each patient receives their Implant Card after implantation and understands its purpose. The Implant Card helps patients identify the implanted device and provides key information for future reference and medical care. The Implant Card must be completed with the relevant patient and implant information and handed over to the patient. The implant card is being provided with the implant but can additionally be requested via email at psg- service@paradigmspine.com. For more detailed information please refer to our Implant Card Instructions:
Patient Information
At Paradigm Spine, we believe that clear information helps you make the best decisions about your health. Here you can find our Patient Information Leaflets, which explain our products, how they work, and what you can expect before and after treatment. Please download the leaflet for detailed information about your device, how it is used, and answers to common questions. If you have any further questions, please contact your healthcare professional or reach out to us directly — we are here to help.
The CoFix™ Patient Information Leaflet offers essential information about the implanted device, its purpose, and guidance for post-operative behavior. This document is available below or can be requested by email at psg-service@paradigmspine.com.
Implant Cards
The Implant Card must be completed with the relevant patient and implant information and handed over to the patient. For more detailed information please refer to our Implant Card Instructions
Summary of Safety and Performance (SSCP)
The SSCP is intended to patients clear, updated information on the safety, clinical benefits, and performance of the device. This information can be obtained from our Customer Service team, who will be happy to assist you. Please contact us at psg-service@paradigmspine.com for additional details or support.