![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Orthofix’s 3D-Printed Spacer System for ACDF Procedures Cleared
Orthofix’s 3D-Printed Spacer System for ACDF Procedures Cleared
![ClearanceStamp_Blue.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Blue.gif?t=1576043968&width=430)
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.
Upcoming Events
-
21Oct