Orthopaedic device company 4WEB Medical has secured 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 of the device enables to place the fixation screws through the truss implant and into the adjacent vertebral bodies to form a zero-profile stand-alone construct, helping to eliminate the requirement for supplemental fixation.

4WEB’s device is provided with single-step locking mechanisms

4WEB’s device is provided with single-step locking mechanisms, which helps surgeon users to better perform the stand-alone construct.

The company is offering an anterior lumbar stand-alone product line in various footprints, lordotic angles, and heights.

4WEB also stated that it will deliver the product line in sterile packaging for hospital efficiency and patient safety

ASTS-SA, which is in line with the company’s existing product portfolio, features an advanced structural design that integrates 4WEB’s Truss implant technology.

The struts in the truss implant transfer strain to adjacent cellular material under normal loading conditions to stimulate a mechanobiologic response.

In addition, the company is planning to introduce a stand-alone lateral lumbar implant by the end of this year.

4WEB Medical sales and marketing senior vice president Jim Bruty 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.”

Established in 2008, 4WEB Medical produces products such as the Cervical Spine Truss System, the Anterior Spine Truss System, the Posterior Spine Truss System, the Lateral Spine Truss System, and the Osteotomy Truss System.

In August 2019, 4WEB Medical secured 510(k) clearance from the FDA for its Cervical Spine Truss System-Stand Alone (CSTS-SA) interbody fusion device.