SI-BONE Receives FDA Clearance for iFuse-3D

By Julie A. Vetalice

SI-BONE received FDA 510(k) clearance and commenced full U.S. launch of the iFuse-3D™ Implant, featuring a patented fenestrated design with an enhanced porous surface designed to mimic the trabecular structure of cancellous bone.

Last month, the U.S. Patent and Trademark Office issued Patent No. 9,662,157 covering structural features of the device, extending IP protection of design until September 2035.

A study, published in June 2017 in the International Journal of Spine Surgery titled "Fortifying the Bone-Implant Interface: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants," indicated significant bone growth on and into the implant's porous surface (Figure 1) as well as through its fenestrations (Figure 2).

Source: SI-BONE, Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory