US-based orthopaedic device company 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 device has an advanced structural design and is the latest addition to the company’s Truss Implant Technology portfolio.
ASTS-SA creates a zero-profile stand-alone construct that removes the need for supplemental fixation by allowing fixation screws to be placed through the truss implant and into the adjacent vertebral bodies.
Typically, the struts in the truss implant transfer strain to adjacent cellular material, which stimulates a mechanobiological response.
In addition, the new design features single-step locking mechanisms.
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 organisation 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 company noted that its 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, it added.
4WEB Medical also said that it plans to launch an additional stand-alone lateral lumbar implant later this year.
In 2014, the company launched Osteotomy Truss System that meets a surgeon’s osteotomy needs with 74 size options of foot and ankle implants.
Its existing portfolio includes 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.