FDA Clears Orthofix’s 3D-Printed FORZA Titanium TLIF Spacer System

Orthofix Medical Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its FORZA Ti TLIF Spacer System. The company also announced the first patient implant of the FORZA system.

“The 3D-printed surface technology, titanium material, and implant design all play a role in the bone growth process during fusion,” said Gary Rosenberg, D.O., an orthopedic spine surgeon operating at Orange County Global Medical Center in Santa Ana, Calif., who performed the first patient implant procedure. “The intuitive instrumentation allows for easy insertion, and the optimized porosity and surface features support our goal of fostering bone growth in order to aid with the patient’s fusion.”

Developed to help optimize Transforaminal Lumbar Interbody Fusion (TLIF) procedures, the FORZA Ti Spacer with Nanovate Technology is a titanium 3D-printed interbody featuring an optimized design, porosity and surface that allows bone to grow into and through the spacer. Interbody implants are spacers that surgeons insert between the vertebrae during spinal fusion surgery to help relieve pressure on nerves and hold the vertebrae in place while fusion occurs.
 
The FORZA Ti TLIF Spacer System with Nanovate Technology is available in the United States through a targeted commercial release.
 
“Following quickly behind the recent launch of our new cervical interbody, the CONSTRUX Mini Ti Spacer System, we are excited to introduce our newest 3D-printed titanium lumbar interbody system,” said Orthofix President of Global Spine Kevin Kenny. “The result of our intense focus on bringing solutions to market to meet the current needs of surgeons, the FORZA Ti TLIF Spacer System with our innovative Nanovate Technology will be a key differentiator for surgeons. It will provide access to advanced fusion technology backed by studies that support the proven biological effects of nanoscale features applied to interbody devices.”
 
The FORZA Ti TLIF Spacer System features include:

• 3D-printed porous titanium with macro, micro, and nanoscale surface features
• Nanoscale surface that has been shown to increase proliferation and alkaline phosphatase activity (an early osteogenic differentiation marker) in human stem cells in-vitro*
• Endplates with 400 micron pores and 50-percent porosity designed to help facilitate bone ingrowth**
• Functional gradient porous structure with 80-percent porosity at the midline of the implant which allows for increased fluoroscopic visualization
• Large open graft window for packing bone-grafting material
• Bulleted nose to assist with distraction
• Straightforward instrumentation for easy implantation

 
Featuring Orthofix’s unique Nanovate Technology, the FORZA Ti TLIF Spacer System is one of many products with nanotechnology FDA clearance including the recently launched CONSTRUX Mini Ti Spacer System, CONSTRUX Mini PTC Spacer System, the Pillar SA PTC Spacer System, and the FORZA PTC Spacer System. When compared to solid PEEK devices, the 3D-printed endplates of implants show a significant increase in growth factors involved in osteogenesis and osteoblast maturation resulting in a more favorable osteogenic environment for bone ingrowth.
 
*As suggested in an in-vivo ovine lumbar spinal fusion model
**In-vitro performance may not be representative of clinical performance