Le Lézard
Classified in: Health
Subject: FDA

4WEB Medical Receives 510(k) Clearance for its Lumbar Plating Solution


DALLAS, March 17, 2021 /PRNewswire/ -- 4WEB Medical, an orthopedic device company focused on developing innovative implants with an Advanced Structural Design utilizing its proprietary Truss Implant Technologytm, announced today that the company has received 510(k) clearance from the U.S. Food & Drug Administration to market its Lumbar Plating Solution (LSTS-PS).

The new plating solution consists of a wide variety of modular plating configurations to address multiple lumbar spine pathologies and approaches. The device provides an integrated and non-integrated offering with a one, two and four screw option. The plate design also features a single-step locking mechanism to prevent screw backout.

"Our continued commitment to new product development led to revenue growth in FY 2020 driven by the lauch of the Stand Alone Cervical and ALIF product lines,"  said Jim Bruty, Sr. Vice President of Sales and Marketing. "The Lumbar Plating Solution will contribute significantly to 2021 top line growth by enabling surgeon customers to utilize the company's Truss Implant Technology in more advanced lateral procedures such as anterior longitudinal ligament release techniques."

The latest addition to the 4WEB portfolio further demonstates the company's commitment to developing a comprehensive lateral spine program. The company currently has procedural-based solutions developed for Direct Lateral, Anterior-to-Psoas (ATP),  and Prone Lateral approaches to the lumbar spine. The company also has dedicated resources for future development of a novel lateral deformity solution.

4WEB expects to lauch it's hyperlordotic lateral impant line and an Anterior-to-Psoas implant by the end of the year making the 4WEB Total Lateral Solution one of the most comprehensive offerings in the lateral spine space.

About 4WEB Medical
4WEB Medical, founded in 2008 in Dallas, TX, is an implant device 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, along with cutting-edge 3D printing technology, to develop 4WEB Medical's proprietary truss implant platform. The 4WEB Medical product portfolio includes the Cervical Spine Truss Systemtm, the Anterior Spine Truss Systemtm, the Posterior Spine Truss Systemtm, the Lateral Spine Truss Systemtm, and the Osteotomy Truss Systemtm. 4WEB is actively developing truss implant designs for tumor, trauma, and patient-specific orthopedic procedures.

SOURCE 4WEB Medical


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