4WEB Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Stand-Alone Anterior Lumbar Interbody Fusion Device (ASTS-SA).
The new design allows fixation screws to be placed through the truss implant and into the adjacent vertebral bodies creating a zero-profile stand-alone construct that removes the need for supplemental fixation. Additionally, the device features single-step locking mechanisms that provide surgeon users confidence in the performance of the stand-alone construct. The anterior lumbar stand-alone product line will be available in multiple footprints, lordotic angles, and heights. The product line will be delivered in sterile packaging for hospital efficiency and patient safety.
“We are excited to add another spine interbody implant to our Truss Implant Technology portfolio,” said Jim Bruty, senior vice president of sales and marketing. “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.”
Consistent with 4WEB’s existing product portfolio, ASTS-SA incorporates the company’s proprietary Truss Implant Technology. Under normal loading conditions, the struts in the truss implant transfer strain to adjacent cellular material which stimulates a mechanobiologic response.
This is the second 510(k) clearance 4WEB Medical has received in 2020. The company has additional plans to launch a stand-alone lateral lumbar implant later this year.