FDA clears 4Web Medical’s cervical spine implant
4Web Medical said yesterday that it received FDA 501(k) clearance to market its cervical spine truss system-stand alone (CSTS-SA) interbody fusion device.
The CSTS-SA contains a single-step locking mechanism designed to give surgeon users confidence in a stand-alone construct that is meant to place fixation screws through the truss implant and into adjacent vertebral bodies, removing the need for traditional plate-and-screw fixation.
The truss technology is designed to simulate cellular activity at the surgical site. In-vitro testing has shown that stem cells attached to 4WEB’s titanium implant surface displayed increased gene expression of certain osteogenic markers, according to a release.
Frisco, Texas-based 4Web Medical said it plans to get the device on the 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,” senior vice president of sales and marketing Jim Bruty said in prepared remarks. “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.”
Original Article: (https://www.massdevice.com/fda-clears-4web-medicals-cervical-spine-implant/)