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

By Julie A. Vetalice

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

4WEB Medical was granted FDA 510(k) clearance from to market its Lumbar Plating Solution (LSTS-PS).

The new system comprises a 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.

The company expects to launch its hyperlordotic lateral implant line and an Anterior-to-Psoas implant by the end of 2021.

"Our continued commitment to new product development led to revenue growth in FY 2020 driven by the launch 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."

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory