Orthofix Medical has announced the US Food and Drug Administration (FDA) has given 510(k) clearance for its 3D-printed Construx mini titanium spacer system. In a company press release, it was also announced that the first patient had been implanted with the device.
According to Orthofix, the system is developed to enhance anterior cervical discectomy and fusion (ACDF) procedures and the system is the first 3D-printed titanium interbody introduced to the market by Orthofix.
“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, an orthopaedic spine surgeon operating at Loma Linda University Medical Center in Loma Linda, USA, who performed the first patient implant procedure. “The Construx mini titanium system’s optimised porosity and surface allows bone to grow into and through the spacer in order to aid with the patient’s fusion.”
According to the company, the Construx mini titanium spacer system features include:
- 3D-printed porous titanium with macro, micro, and nanoscale surface features
- Nanoscale surface that has been shown to increase proliferation and alkaline phosphatase activity (an early osteogenic differentiation marker) in human stem cells in vitro
- Endplates with 400 micron pores and 50% porosity designed to help facilitate bone ingrowth
- Functional gradient porous structure with 80% porosity at the midline of the implant which allows for increased fluoroscopic visualisation
- Large centre opening with concaved inner walls for packing bone-grafting material
- Straightforward instrumentation for easy implantation