The coflex® implant is intended for permanent implantation between the spinous processes of 1 or 2 lumbar motion segments (L1-L5) and controls segmental motion in cases of lumbar stenosis or mild degenerative instability. The coflex® implant may also be used in up to 2 lumbar motion segments adjacent to fused level(s).

Implantation Parameters

A maximum of two (2) coflex® implants may be implanted per patient. Each implant is intended for use at a single lumbar motion segment, and the coflex® system is approved for treatment of up to two (2) lumbar motion segments (L1–L5).

Material

The coflex® implant is made from wrought titanium 6-aluminum 4-vanadium alloy (ISO 5832-3 and ASTM F136). It is supplied sterile and is available in numerous size.

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 coflex® implant is intended to be used exclusively in combination with the designated coflex® instruments. The correct and safe use of the implant is ensured only when the associated surgical instruments specified for the coflex® system are utilized. The complete list and description of these designated instruments are provided in the coflex® Surgical Technique Guide (STG-00040). This guide outlines the appropriate surgical steps, instrumentation, and procedures necessary for safe and effective implantation and removal.
The Surgical Technique Guide (STG-00040) is available below:

Summary of Safety and Performance (SSCP)

In accordance with the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745), Paradigm Spine provides access to the Summary of Safety and Clinical Performance (SSCP) 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.
Please refer to the link below to view or download the current SSCPs:

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:

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 coflex® 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. Please refer to the link below to view or download the current SSCPs