Elevation Spine Wins FDA Nod for ACDF System with 3D-Printed Interbody

Elevation Spine announced that it’s obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for Saber-C AVIA, a zero-profile anterior cervical discectomy and fusion (ACDF) construct.

Saber-C AVIA, the latest in the Saber platform, boasts the biomechanical stability historically associated with traditional plating. It also features a porous 3D-printed titanium interbody with options for both spike and screw fixation.

The redesigned Saber-C AVIA system features a lower-profile workflow with refined spike instrumentation, new screw instruments, and a low-profile screw inserter. Both spike and screw options are included in a single tray, providing versatility across a range of ACDF cases.

The implant is available in 6° lordotic and 12° hyperlordotic options with a large central graft window.

The porous 3D-printed titanium interbody touts a 55% porosity lattice structure that’s designed to mimic trabecular bone. Based on Elevation Spine’s preclinical data, Saber-C AVIA’s porous structure is associated with bone ingrowth.

“Our dedicated Saber-C surgeon community gave us valuable feedback, and those conversations shaped what came next,” said CEO Charlie Gilbride. “We focused on purposeful instrumentation, a porous 3D titanium implant supported by preclinical research, and thoughtful refinements that build on the strengths of the original platform. Our size is one of our greatest advantages. We stay close to our surgeon network, move quickly on their feedback, and remain focused on delivering meaningful innovation where it matters most.”