4WEB Medical, the industry leader in 3D printed orthopedic implants, announced today that the company has received 510K clearance from the FDA for its lateral interbody fusion device. The company will market the comprehensive lateral offering under the trade name Lateral Spine Truss System.
"The Lateral Spine Truss System represents a significant advancement in treatment options for lateral spine surgery," said Frank Cammisa, MD, Professor and Chief Emeritus of the Spine Service at Hospital for Special Surgery in New York City. "As evidenced in recent porous metal product launches, many companies have failed to recognize the full design potential of what 3D printing brings to the orthopedic arena. 4WEB's proprietary truss implant technology leverages fundamental engineering principles in structural mechanics to address important clinical issues such as implant subsidence after lateral access surgery."
The Lateral Spine Truss System launch will include a wide array of sizing options and integrated instrumentation. Additionally, the lateral implants will feature smart single-sterile packaging to ensure sterility, improve operating room efficiencies, and allow access to global markets where sterile packaging is a requirement.
"4WEB has achieved a significant milestone that allows us to address the majority of fusion procedures and approaches performed today. We now offer Truss Implant Technology for every mainstream surgical technique used in spine surgery," said Jim Bruty, Sr. Vice President, Sales and Marketing of 4WEB. "4WEB will continue to be on the cutting edge with meaningful innovation in spine surgery by pioneering implant function through structural design."
Source : finance.yahoo.com