Orthofix’s 3D-Printed Spacer System for ACDF Procedures Cleared
Orthofix has been granted 510(k) clearance by the FDA for its CONSTRUX Mini Ti Spacer System, a 3D-printed implant for enhancing anterior cervical discectomy and fusion (ACDF) procedures.
The 3D-printed titanium interbody implant is the first to receive regulatory clearance for ACDF procedures, the company said. The spacer system features endplates with 50-percent porosity to enhance bone ingrowth. It also includes a gradient porous structure at its midline that mimics the natural porous structure of bone and improves fluoroscopic visualization.
ACDF procedures, which involve replacing a damaged cervical disc with an interbody implant packed with a fusion-promoting biologic, are frequently used to treat herniated cervical discs or degenerative disc disease, Orthofix said.