Life Spine’s FDA 510(k) for GHOST 3D-printed titanium spacer system

Life Spine, a leading medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spinal disorders, announced that it’s received clearance from the U.S. Food & Drug Administration (FDA) to market the GHOST 3D-printed titanium spacer systems.

GHOST 3D-printed titanium spacer system expands on Life Spine’s interbody portfolio, comprised of PEEK, titanium, and now 3D-printed titanium spacers. The new implants include solutions for ALIF, PLIF/TLIF and Lateral procedures.

GHOST spacers integrate porous surfaces designed to promote bony on-growth while maintaining a robust external lattice geometry. GHOST is available in a wide range of footprints and lordotic offerings to accommodate varying patient anatomies and pathologies. The system features streamlined instrumentation and is supplemented by Life Spine’s wide variety of posterior fixation including AVATAR percutaneous screw system, NAUTILUS spinal fixation system, CENTERLINE midline screw system and ARx spinal fixation system.

“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 customize their patient’s treatment,” says Mariusz Knap, sr. vice president of marketing.

GHOST key features and benefits:

• Integrated porous structure within the endplate surfaces and along the graft window column
• Wide array of footprints, heights, and lordotic offerings for ALIF, PLIF/TLIF, and Lateral approaches
• Large graft windows to allow for packing bone graft material
• Smooth bulleted tip and streamlined instrumentation designed for intuitive insertion