4Web Medical this week said it received FDA 510(k) clearance for its Stand-Alone Anterior Lumbar Interbody Fusion Device.
The fusion device is designed to allow fixation screws to be placed through the truss implant and into the adjacent vertebral bodies to create a zero-profile stand-alone construct that removes the need for supplemental fixation.
The device features single-step locking mechanisms and incorporates the company’s Truss Implant Technology to transfer strain to adjacent cellular material to stimulate mechanobiologic response.
“We are excited to add another spine interbody implant to our Truss Implant Technology portfolio,” senior VP of sales and marketing Jim Bruty said in a news release. “The addition of the Stand-Alone Anterior Spine Truss System not only broadens our current offering, but we anticipate this launch to provide significant growth to the organization for the remainder of 2020. 4WEB will continue to stay focused on investments in product development, clinical research, and procedural-based solutions as a means to achieving our long-term growth strategy.”
The anterior lunar stand-alone product line will be available in multiple footprints, lordotic angles and heights. It will also be delivered in sterile packaging for hospital efficiency and patient safety, according to the company.