Orthofix Gains FDA Clearance for 3D-Printed CONSTRUX Mini Ti Spacer

By Julie A. Vetalice

Orthofix Gains FDA Clearance for 3D-Printed CONSTRUX Mini Ti Spacer

Orthofix Medical announced FDA 510(k) clearance and the first patient implant of the 3D-printed CONSTRUX™ Mini Ti Spacer. Developed to enhance anterior cervical discectomy and fusion, CONSTRUX Mini Ti with Nanovate™ Technology is the company's first 3D-printed titanium interbody.

When compared to solid PEEK devices, the 3D-printed endplates of Nanovate implants show a significant increase in growth factors involved in osteogenesis and osteoblast maturation, resulting in a more favorable osteogenic environment for bone ingrowth.

The CONSTRUX Mini Ti Spacer System features:

  • 3D-printed porous titanium with macro, micro and nanoscale surface features
  • 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 center opening with concaved inner walls for packing bone graft

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory