Orthofix Gains FDA Clearance for 3D-Printed FORZA Titanium TLIF Spacer

By Julie A. Vetalice

Orthofix Gains FDA Clearance for 3D-Printed FORZA Titanium TLIF Spacer

Orthofix Medical announced FDA 510(k) clearance and first patient implant of the FORZA™ Ti Transforaminal Lumbar Interbody Fusion Spacer. Targeted U.S. commercial release is underway.

The FORZA Ti TLIF Spacer 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% porosity designed to help facilitate bone ingrowth
  • Functional gradient porous structure with 80% porosity at the midline of the implant for increased fluoroscopic visualization
  • Large open graft window for packing bone grafting material
  • Bulleted nose to assist with distraction
  • Straightforward instrumentation

“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.”

Product Labels: Lumbar Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory