4WEB Medical receives FDA 510(k) clearance for its CSTS-SA Interbody Fusion Device
DALLAS—Thirty years of research in topological dimension theory led to the discovery of a novel geometry, the 4WEB, that can be used as a building block to create high-strength, lightweight web structures. 4WEB Medical leveraged this breakthrough, along with cutting-edge 3D printing technology, to develop its proprietary truss implant platform.
The company, founded in 2008 in Dallas, Texas, is an orthopedic device company that works to develop innovative implants using its proprietary Truss Implant Technology™. Fast forward 11 years, and 4WEB Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Cervical Spine Truss System-Stand Alone (CSTS-SA) Interbody Fusion Device.
The CSTS-SA is said to be consistent with 4WEB’s existing product portfolio in that it has an open architecture, advanced structural design that incorporates the company’s proprietary Truss Implant Technology™. It is designed to allow 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 traditional plate-and-screw fixation, according to 4WEB Medical.
The device also provides a single-step locking mechanism that is said to provide surgeons (users) with confidence in the performance of the stand-alone construct.
The Cervical Stand-Alone product line will be available in multiple footprints, lordotic angles, and heights, and will be delivered in sterile packaging for hospital efficiency and patient safety. 4WEB Medical said that it expects to take the product to market at the beginning of the fourth quarter.
“We are thrilled to be able to expand our market leading portfolio in the titanium interbody space,” said Jim Bruty, senior vice president of sales and marketing for 4WEB Medical, in the release. “The addition of the Cervical Spine Truss System-Stand Alone product line not only broadens our current portfolio but represents the first of many products to be released that will provide significant growth for the organization. 4WEB will continue to provide clinicians with disruptive, clinically beneficial technology achieved through product development.”
4WEB Medical (https://4webmedical.com/) said that its proprietary Truss Implant Technology™ uses the concept of mechano-biology to simulate cellular activity at the surgical site. The manufacturing process used to produce the implant’s structural design creates a hierarchical surface roughness with features that span from the macro scale to the nano scale. In-vitro testing has shown that stem cells attached to 4WEB’s titanium implant surface exhibited increased gene expression of certain osteogenic markers when compared to smooth titanium and PEEK, the company said.