Home 3d Printing FDA clears Orthofix 3D-printed titanium cervical spacer system

FDA clears Orthofix 3D-printed titanium cervical spacer system


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

Lewisville, Texas–based Orthofix also administered the first patient implant of the 3D-printed Construx Mini Ti system, which is designed to enhance anterior cervical discectomy and fusion (ACDF) procedures, according to a news release.

The Construx Mini Ti cervical spacer includes Nanovate technology is touted as the first 3D-printed titanium interbody implant to be introduced onto the market by Orthofix.

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

The system includes 3D-printed porous titanium with macro, micro and nanoscale surface features, the latter of which increases proliferation and alkaline phosphatase activity in human stem cells in vitro. Additionally, the endplates are designed to facilitate bone ingrowth, while the gradient porous structure allows for increased fluoroscopic visualization.

“Orthofix’s cervical spine offerings feature a wide array of implants ranging from motion-preserving products like the M6-C artificial cervical disc to advanced interbody and fixation solutions that aid surgeons in restoring spinal alignment and decreasing pain and nerve compression,” Orthofix president of global spine Kevin Kenny said in the release.

“We are dedicated 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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