Elevation Spine Wins FDA Clearance for Saber-XA
Elevation Spine has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Saber-XA™, an anterior lumbar interbody fusion (ALIF) system designed to provide greater flexibility during spinal fusion procedures.
Saber-XA combines an expandable cage with a zero-profile anterior lumbar plate, enabling surgeons to adjust implant height and lordotic angle during surgery according to patient anatomy.
The system provides multiple configurations within its expansion range, including hyperlordotic options.
The device features 3D-printed titanium endplates and is available in three footprints, with three sizes for each footprint.
This allows surgeons to access a broad range of implant height and lordosis configurations from nine implant sizes, potentially reducing inventory requirements compared with static ALIF systems.
Saber-XA also provides both inline spike fixation and self-drilling screw options through a single instrument tray.
Its separately applied anterior lumbar plate uses a zero-profile design positioned away from major blood vessels and the front of the spinal column.
The anterior lumbar plate has undergone testing to demonstrate independent spinal support and has received FDA clearance as an anterior lumbar plate.
The regulatory clearance strengthens Elevation Spine’s portfolio of adaptable technologies for lumbar fusion procedures and supports its efforts to simplify implant selection and surgical workflows.
