4WEB Medical: 510(k) for Lateral Interbody Fusion Device

4WEB Medical is announcing the receipt of 510(k) clearance from the FDA for its lateral interbody fusion device. The trade name is “Lateral Spine Truss System.”

“The Lateral Spine Truss System represents a significant advancement in treatment options for lateral spine surgery, ” said Frank Cammisa, M.D., in the July 27, 2016 news release. Dr. Cammisa is 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.”

“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 company SVP, Sales and Marketing Jim Bruty. “4WEB will continue to be on the cutting edge with meaningful innovation in spine surgery by pioneering implant function through structural design.”

Bruty told OTW, “The most interesting part of the product development and regulatory process was the ultimate conception of a novel truss implant design for lateral access surgery that leverages the capabilities of 3D printing far beyond what other spine companies are achieving.”

“The LSTS [Lateral Spine Truss System] leverages engineering principles such as structural mechanics to reduce subsidence related complications. The LSTS has an open architecture that maximizes graft volume. It has a unique implant surface texture that reduces the chance of migration. The bi-convex surface of the LSTS brings the implant closer to adjacent bone.”