Elevation Spine, a specialist in integrated-fixation technologies for spinal surgery, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its newest cervical fixation device, Saber-C AVIA.
The product is the latest addition to the company’s Saber platform and is designed for use in anterior cervical discectomy and fusion (ACDF) procedures.
Saber-C AVIA has been engineered as a zero-profile construct aimed at providing biomechanical stability similar to that of traditional plate systems.
The system incorporates a porous, 3D-printed titanium interbody implant with options for both spike and screw fixation. These features allow for flexibility and adaptability during surgery.
It is structured to offer a streamlined workflow, with enhancements to multiple instruments in the kit.
Most of the original Saber-C spike delivery instruments have been modified to improve precision while the system now also includes new screw delivery options with an especially low-profile screw inserter.
Both spike and screw instrumentation are supplied together in a single tray, which the company states is intended to offer maximum versatility for surgeons handling a broad range of ACDF cases.
The interbody implant within Saber-C AVIA features a lattice structure with 55% porosity, which has been engineered to replicate the architecture of trabecular bone.
Elevation Spine CEO Charlie Gilbride said: “Our dedicated Saber-C surgeon community gave us valuable feedback, and those conversations shaped what came next.
“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.”
Saber-C AVIA is available for surgical use in the US.
