Orthofix Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its 3D-printed CONSTRUX Mini Ti Spacer System.

The company has also announced the first patient implant of the 3D-printed titanium cervical spacer system with Nanovate technology.

Orthofix has designed the CONSTRUX Mini Ti Spacer System to improve the anterior cervical discectomy and fusion (ACDF) procedures.

According to the company, the 3D-printed endplates of Orthofix’s implants with Nanovate technology demonstrated a significant increase in growth factors involved in osteogenesis and osteoblast maturation resulting in better osteogenic environment for bone ingrowth.

The CONSTRUX Mini Ti Spacer System consists of 3D-printed porous titanium with macro, micro, and nanoscale surface features and nanoscale surface that was demonstrated to enhance proliferation and alkaline phosphatase activity in human stem cells in vitro.

Its other features include endplates with 400 micron pores and 50% porosity designed to facilitate bone ingrowth and functional gradient porous structure with 80% porosity at the midline of the implant to increase fluoroscopic visualisation.

In addition, the system includes a large centre opening with concaved inner walls for packing bone-grafting material.

Orthofix global spine president Kevin Kenny said: “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’s with nanotechnology FDA clearance include CONSTRUX Mini PTC Spacer System, Pillar SA PTC Spacer System and FORZA PTC Spacer System.

In February this year, Orthofix commercially launched its FITBONE intramedullary lengthening system in the US and European markets.

The FITBONE system has been designed for limb lengthening and deformity correction of the femur and tibia bones.