4WEB Medical Gains FDA Clearance for Stand-Alone Anterior Lumbar Interbody Fusion

By Julie A. Vetalice

4WEB Medical Gains FDA Clearance for Stand-Alone Anterior Lumbar Interbody Fusion

4WEB Medical received FDA 510(k) clearance to market its Stand-Alone Anterior Lumbar Interbody Fusion Device (ASTS-SA). This is the second 510(k) clearance 4WEB Medical has received in 2020, following the Stand-Alone Cervical Spine Truss. The company has additional plans to launch a stand-alone lateral lumbar implant later this year.

The design allows fixation screws to enter the truss implant and adjacent vertebral bodies, creating a zero-profile stand-alone construct with single-step locking mechanisms. The device will be available in multiple footprints, lordotic angles and heights delivered in sterile packaging.

Like other products in the company's portfolio, ASTS-SA is based on the 4WEB's proprietary Truss Implant Technology™ through which struts in the truss implant transfer strain to adjacent cellular material, yielding a mechanobiologic response.

Jim Bruty, Senior Vice President of Sales and Marketing, said, "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."

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory