65-C-1517-8-6L: Xtant Medical Fortilink-C Interbody Fusion Device IBF System w/TETRAfuse 3D 14.5mm x 17mm x 8mm, 6°

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Xtant Medical Fortilink-C IBF System w/TETRAfuse 3D Technology

The Fortilink®-C IBF (Interbody Fusion) System with TETRAfuse® 3D Technology is an innovative cervical interbody device designed for use in Anterior Cervical Discectomy and Fusion (ACDF) procedures. Developed by Xtant Medical, this system incorporates advanced materials and 3D printing technology to optimize spinal fusion outcomes.

Key Features:

TETRAfuse® 3D Technology

• 3D-Printed Polymer Material: Combines the beneficial properties of titanium and PEEK (polyetheretherketone), offering an ideal balance of strength, biocompatibility, and bone integration.
• Bone-Friendly Surface: Features a nano-rough surface that encourages the attachment and proliferation of bone cells, promoting better osseointegration.
• Radiolucency: Unlike metal implants, the TETRAfuse material is radiolucent, allowing surgeons to monitor the progression of bone fusion using X-rays without obstruction.
• Biomechanical Compatibility: The device mimics the mechanical properties of bone, reducing stress shielding and allowing for effective load sharing during healing.

Design and Functionality

• Graft Window: Large central cavity designed to hold bone graft material, encouraging robust fusion between vertebrae.
• Anatomical Fit: Available in a variety of sizes to accommodate different patient anatomies, ensuring proper alignment and stability during and after surgery.

Clinical Applications

The Fortilink-C IBF System is used in ACDF procedures for patients with:

• Degenerative disc disease in the cervical spine.
• Herniated cervical discs requiring surgical intervention.
• Other conditions where stabilization and fusion of the cervical vertebrae are necessary.

Advantages

• Enhanced Fusion Potential: The nano-rough surface and graft window facilitate bone integration and ingrowth.
• Clear Postoperative Imaging: Radiolucent material allows for unobstructed imaging to assess the fusion site.
• Minimized Stress Shielding: Bone-like mechanical properties encourage natural load sharing across the spine.

FDA Approval

The Fortilink-C IBF System with TETRAfuse 3D Technology received FDA clearance and has been in use clinically since its introduction in 2017. It represents a significant advancement in cervical spinal fusion technology by combining the benefits of advanced materials and 3D printing.

Xtant Medical is a leading provider of regenerative medicine and orthopedic solutions, specializing in advanced technologies for spinal fusion, fixation, and biologics. With a commitment to innovation and quality, Xtant has expanded its portfolio through strategic acquisitions, including the Fortilink® series of interbody fusion (IBF) systems featuring TETRAfuse® 3D Technology. These cutting-edge implants are designed to facilitate bone growth and fusion while offering bone-like mechanical properties, making them ideal for procedures such as anterior cervical discectomy and fusion (ACDF) and other spine fusion surgeries.

Notable products in Xtant’s portfolio include the Axle® Interspinous Fusion System, OsteoSponge® allografts for bone regeneration, and 3Demin® solutions for advanced healing. The addition of the Fortilink®-A, Fortilink®-C, and Fortilink®-TS IBF Systems further reinforces Xtant’s position as a trusted partner for spine surgeons, providing innovative tools to address complex spinal conditions.

With its comprehensive range of biologics, implants, and hardware, Xtant Medical empowers healthcare professionals to improve patient outcomes and restore quality of life through precision and advanced care in spinal surgery.