Press release
Orthofix Announces FDA Clearance and Initial Patient Implant of the Company’s First 3D-Printed Titanium Cervical Spacer System with Nanovate Technology
Designed with nanoscale surface features, the CONSTRUX Mini Ti System is Orthofix’s first 3D-printed titanium (Ti) interbody introduced to the market.
About this update from Orthofix Medical Inc.
[{"type":"text","content":"\nDesigned with nanoscale surface features, the CONSTRUX Mini Ti System is Orthofix’s first 3D-printed titanium (Ti) interbody introduced to the market.\n\n LEWISVILLE, Texas--(BUSINESS WIRE)--\nOrthofix Medical Inc. (NASDAQ:OFIX), a global medical device company with a spine and extremities focus, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and the first patient implant of the 3D-printed CONSTRUX™ Mini Ti Spacer System. Developed to enhance anterior cervical discectomy and fusion (ACDF) procedures, the CONSTRUX Mini Ti cervical spacer with Nanovate™ Technology is the first 3D-printed titanium interbody introduced to the market by Orthofix.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210405005029/en/Image of Orthofix’s first 3D-printed titanium interbody, the CONSTRUX™ Mini Ti Cervical Spacer System with Nanovate™ Technology. (Photo: Orthofix Medical Inc.)\n“The ACDF procedure, which is often used to treat a herniated cervical disc or degenerative disc disease, involves replacing a patient’s damaged cervical disc with an interbody packed with a biologic to promote fusion in order to provide stability and strength to the area,” said Wayne Cheng, M.D., an orthopedic spine surgeon operating at Loma Linda University Medical Center in Loma Linda, CA, who performed the first patient implant procedure. “The CONSTRUX Mini Ti System’s optimized porosity and surface allows bone to grow into and through the spacer in order to aid with the patient’s fusion.”\n\nThe CONSTRUX Mini Ti Spacer System with Nanovate Technology is one of many Orthofix products with nanotechnology FDA clearance including the CONSTRUX™ Mini PTC Spacer System, the Pillar™ SA PTC Spacer System, and the FORZA™ PTC Spacer System. When compared to solid PEEK devices, the 3D-printed endplates of these implants with Nanovate Technology show a significant increase in growth factors involved in osteogenesis and osteoblast maturation resulting in a more favorable osteogenic environment for bone ingrowth.\n\n“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 comp...