The Fortilink®-C Ti is an interbody fusion device intended for the cervical spine (C2-T1) in patients with degenerative disc diseases. The Fortilink® -C Ti interbody fusion devices are manufactured with SLM (selective laser melting) and are built up from implant grade titanium alloy (Ti6Al4V). The Fortilink® -C Ti has an open mesh structure and a bone window both designed to allow bone ingrowth and facilitate fusion. The box-shaped design is intended to provide primary stability and increase the intervertebral height and lordosis.
The Fortilink® -C Ti implant will be used in combination with:
Intended Purpose
The Fortilink®-C Ti is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instabilities at one or two contiguous levels from C2 to T1 with accompanying radicular symptoms, ruptured or herniated discs, and pseudarthrosis or failed spondylodesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is implanted via an anterior approach. The Fortilink®-C Ti devices are intended to be used with supplemental fixation designed for the implanted level. This system is to be used in patients who have had six weeks of non-operative treatment.
Implantation Parameters
Intended Body Region: Cervical spine (C2 to T1)
Patient Population: Skeletally mature patients with degenerative disc disease (DDD) and spinal instabilities, including those with radicular symptoms, herniated or ruptured discs, pseudarthrosis, or previously failed spondylodesis, after at least six weeks of non-operative treatment.
Intended Benefits:
- Reduction of neck pain
- Clinical improvement
- Facilitation of spinal fusion
- Restoration or increase of intervertebral height
- Improvement of cervical lordosis
Material
The implants are manufactured from implant grade titanium alloy Ti6Al4V ELI (ASTM F3001)
Surgical Technique Guide
The Surgical Technique Guide is available here:
End User Information - BAAT Medical | Full Service Device Development
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.
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 resources, which explain our products, how they work, and what you can expect before and after treatment. If you have any further questions, please contact your healthcare professional or reach out to us directly — we are here to help. Please contact us at psg-service@paradigmspine.com for additional details or support.
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.