FDA Clears 4WEB Medical’s New Integrated Cervical Plate

4WEB Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the Cervical Spine Truss System (CSTS) Integrated Plating Solution and two cervical interbody line extensions that include implants with 12 degrees of lordosis as well as a large footprint option (16mm x19mm).
 
“The CSTS Integrated Plating Solution provides an additional stand-alone treatment option for 4WEB’s surgeon customers. With two product launches in Q3 and regulatory clearance for the integrated plate, we have built significant momentum towards completing the company’s comprehensive cervical portfolio by the end of the year,” 4WEB R&D Director Jonathan Hires said.  
 
The CSTS Integrated Plating Solution clearance follows several recent milestones including the launch of a non-integrated cervical plating solution and a second-generation cervical interbody fusion device that debuted in Q3.  Additionally, the company has previously announced plans to launch an integrated anchor fixation system in early Q4. The expanded suite of products will provide a variety of cervical fusion constructs for varying anatomical needs. 
 
“The launch of the CSTS Integrated Plating Solution builds on an already robust product portfolio. We are excited to launch several new cervical products before the end of the year and look forward to capitalizing on this success with significant growth in 2024,” stated Geoff Bigos, vice president of 4WEB Medical’s Spine Division.
 
Founded in 2008 in Dallas, Texas, 4WEB Medical is an orthopedic implant company. 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. The company leveraged this breakthrough to develop 4WEB Medical’s proprietary Truss Implant Technology. 4WEB was the first company to receive FDA 510(k) clearance for an implant manufactured with 3D printing technology. The 4WEB Medical product portfolio includes the Cervical Spine Truss System, the Stand Alone Cervical Spine Truss System, the Stand Alone Anterior Spine Truss System, the Anterior Spine Truss System, the Posterior Spine Truss System, the Lateral Spine Truss System, and the Osteotomy Truss System. The company is actively developing truss implant designs for tumor, trauma, and patient-specific applications.