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Fortilink®-TCimplant
 with TiPlus Technology Product Overview Fortilink®-TC impant eIFU
 The Fortilink®-TC implant with TiPlus technology features a titanium open mesh design with 70% porosity, optimized pore structure, and a nano-roughened surface to promote bone ingrowth, fusion, and spinal stability. Fortilink®-TCimplant
 with TiPlus Technology The Fortilink®-TC implant with TiPlus technology features a titanium open mesh design with 70% porosity, optimized pore structure, and a nano-roughened surface to promote bone ingrowth, fusion, and spinal stability. Product Overview Fortilink®-TC impant eIFU

The Fortilink®-TC Ti is an interbody fusion device intended for the lumbar spine (L2-S1) in patients with degenerative disc diseases. The Fortilink®-TC Ti interbody fusion devices are manufactured with SLM (selective laser melting) and are built up from implant grade titanium alloy (Ti6Al4V). The Fortilink®-TC Ti has an open mesh structure and a bone window both designed to allow bone ingrowth and facilitate fusion. The banana-shaped design is intended to provide primary stability and increase the intervertebral height.

The Fortilink®-TC Ti implant will be used in combination with:

  • Dedicated instrument set (see surgical technique for Catalogue Instruments)
  • General instruments typically used in spinal surgery (including rongeurs, forceps)

Intended Purpose

The Fortilink®-TC Ti is indicated for transforaminal interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The IBF devices are intended to be used with supplemental fixation designed for the implanted level. Patients should have at least six months of non‐operative treatment prior to treatment with an interbody fusion device.

Implantation Parameters

Intended Body Region: Lumbar spine (L2-S1)

Patient Population: Skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Intended Benefits:

  • Decrease back pain, as assessed using the Visual Analogue Scale (VAS)
  • Clinical improvement, as assessed using the Oswestry Disability Index (ODI)
  • Facilitate fusion, assessed by fusion rates in radiological follow-up images
  • Increase in intervertebral height, indirectly assessed by pre- versus post-operative patient functionality (ODI) and pain scores (VAS)

Material

The implants are manufactured from implant grade titanium alloy Ti6Al4V ELI (ASTM F3001)

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

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