Foundation Surgical Gains 510(k) For Lateral Interbody System

Foundation Surgical, an early-stage spinal implant company, has received US Food & Drug Administration 510(k) clearance for its Interwedge Standalone Lateral Interbody System. This latest product clearance, used in conjunction with the company’s new LLIF180 procedure, represents a significant innovation in lateral spinal surgery.
 
Dr. Randal Betz, the founder of Foundation Surgical, shared: “The FDA clearance of the Interwedge system represents a significant step forward for lateral lumbar spine surgery and implant technology. We believe the novelty of the LLIF180 procedure and unique features of the Interwedge system, like the bilateral fixation via the deployable staple, offer surgeons enhanced options for standalone lateral interbody spinal stabilization.”
 
LLIF180 is the first bilateral-fixated standalone-lateral procedure performed through a single-position lateral or oblique-lateral lumbar spine approach. The LLIF180 procedure’s bilateral fixation is made possible by the Interwedge system’s novel deployable staple. 
 
The Interwedge system also features a distinctive hinge mechanism between the spacer and lateral plate which, combined with the deployable staple, provides both ipsilateral and contralateral fixation. These innovations grant the Interwedge system unparalleled versatility and stability to facilitate a lumbar spine fusion while eliminating the need for supplemental posterior fixation.