Life Spine has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its GHOST 3D-Printed Titanium Spacer System.
The new spacer system features endplate surfaces that have a porous structure for promoting bone growth while maintaining an external lattice geometry.
It is available in a variety of footprints, heights and lordotic options for different patient anatomies and pathologies in anterior, posterior and transforaminal lumbar interbody fusion (ALIF, PLIF and TLIF) as well as Lateral method procedures.
The system includes large graft windows to enable packing bone graft material along with a smooth bulleted tip and streamlined instrumentation to provide intuitive insertion capabilities.
It is supplemented by the company’s broad range of posterior fixation offerings, including the Avatar percutaneous screw system and Centerline midline screw system.
Additionally, the company offers the Nautilus and ARx spinal fixation systems.
Life Spine stated that the new GHOST spacer system expands its interbody portfolio, which includes PEEK, titanium and now 3D-printed titanium spacers.
Life Spine Marketing senior vice-president Mariusz Knap said: “We are excited about the expansion of our interbody portfolio to include 3D-printed implants.
“Our robust offering is one of the broadest in the industry and includes solutions for nearly every procedure and surgeon preference.
“With the PEEK, Titanium and Expandable interbody product lines, the addition of 3D-Printed Titanium interbodies allows Life Spine to offer physicians alternative solutions to customise their patient’s treatment.”
The company is engaged in the designing, developing, manufacturing and commercialising of products for the surgical treatment of spinal disorders.
In March, Life Spine obtained 510(k) clearance from the US FDA to market its SImpact Si Joint Fixation System for Posterior-Oblique approaches.