Elevation Spine Receives FDA 510(k) Clearance for Saber-XA™, an Expandable Anterior Lumbar Interbody Fusion (ALIF) System
Elevation Spine announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for
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Elevation Spine announced today that the U.S. Food and Drug Administration (FDA) has granted 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. Saber-XA expandable technology enables true intra-operative customization of implant height and lordosis.
Saber-XA is engineered to streamline anterior lumbar fusion by offering exceptional surgical flexibility. Surgeons can now independently adjust implant height and lordotic angle based on actual patient anatomy, with an infinite number of configurations within the implant’s expansion range. Saber-XA also features a separately applied anterior lumbar plate which has a zero-profile design, positioned away from major blood vessels rather than anterior to the spinal column. The system is offered with both inline spike fixation and self-drilling screw options available in a single instrument tray.
“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 Charlie Gilbride, CEO of Elevation Spine. “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.”
Saber-XA is manufactured with 3D-printed titanium endplates and is available in three footprints with three sizes per footprint. Rather than having to choose between upward of 70 implant sizing options as with a static ALIF system, Saber-XA offers the surgeon every height and lordosis configuration, including hyperlordotic sizes, from only nine total implant sizes. The significant reduction in implant inventory per case simplifies the surgery for the surgeon and support staff.
The Saber-XA Anterior Lumbar Plate is a first-of-its-kind, FDA-cleared zero-profile anterior lumbar plate. This device underwent rigorous testing and demonstrated the ability to independently support the spinal column, achieving the same designation as all other devices cleared as anterior lumbar plates.
About Elevation Spine
Elevation Spine, headquartered in Monterey, Calif., is the leading spinal medical device developer of integrated-fixation technologies. The Saber Technology platform integrates zero-profile, anterior plate fixation with interbody support in both the cervical and lumbar spine. Saber systems are designed to simplify surgical workflow while improving patient outcomes.
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