FDA Clears Elevation Spine’s Saber-XA ALIF System

Elevation Spine has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for Saber-XA, an anterior lumbar interbody fusion (ALIF) system that combines expandable cage technology with a zero-profile, FDA-cleared anterior lumbar plate.

The Monterey, California-based company’s ALIF system is designed for anterior lumbar fusion, allowing surgeons to independently adjust implant height and lordotic angle to match patient anatomy. It features a separately applied, zero-profile anterior plate positioned away from major blood vessels, with inline spike and self-drilling screw fixation options available in a single instrument tray.

Saber-XA features 3D-printed titanium endplates and nine implant sizes across three footprints, offering adjustable height and lordosis, including hyperlordotic configurations. According to Elevation Spine, the system reduces the number of implants needed compared with static ALIF systems, simplifying inventory management.

“This 510(k) clearance represents exactly what we set out to achieve with Saber-XA: true intra-operative customization of height and lordosis, something no competing ALIF system offers in combination with both spike and screw fixation along with an anterior lumbar plate,” said CEO Charlie Gilbride. “Surgeons want flexibility and maximum optionality in the OR, and that’s what this system delivers. When a surgeon utilizes Saber-XA, they’re getting a device that removes constraints, not adds them. That’s the Elevation difference.”

Last month, the company earned 510(k) clearance for Saber-C AVIA, a zero-profile anterior cervical discectomy and fusion (ACDF) construct.