FDA Approves Orthofix 3D Printed Titanium Cervical Spacer System

Orthofix Medical (NSDQ: OFIX) announced today that it has received FDA 510 (k) clearance for its Construx Mini Ti spacer system.

Orthofix, of Lewisville, Texas, also administered the first patient implant of the 3D-printed Construx Mini Ti system, designed to improve anterior cervical discectomy and fusion (ACDF), according to a press release.

The Construx Mini Ti Cervical Spacer with Nanovate technology is touted as the first 3D printed titanium interbody implant to be launched by Orthofix.

The endplates of the implants showed a significant increase in growth factors involved in osteogenesis and osteoblast maturation, resulting in a more favorable osteogenic environment for bone ingrowth, Orthofix said.

The system includes 3D-printed porous titanium with macro-, micro- and nano-scale surface features, the latter increasing the proliferation and activity of alkaline phosphatase in human stem cells in vitro. In addition, the end plates should facilitate bone ingrowth, while the porous structure with gradients enables improved fluoroscopic visualization.

“Orthofix’s offering for the cervical spine includes a wide range of implants, from motion-sustaining products like the M6-C artificial neck disc to advanced interbody and fixation solutions that help surgeons re-align the spine and reduce pain and support nerve compression, “Orthofix, President of Global Spine Kevin Kenny said in the publication.

“We are committed to expanding our comprehensive cervical spine solutions with technologies like the Construx Mini Ti Spacer System that can make a meaningful difference in our product offerings and in the lives of patients.”

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