Our sister publication, Medical Device & Outsourcing reports that Si-Bone won FDA 510(k) clearance for its 3D-printed titanium iFuse-3D implant designed for fusion procedures to treat certain disorders of the sacroiliac joint.
The San Jose, Calif.–based company said that the iFuse-3D is the first ever 3D-printed titanium implant designed for use in the sacroiliac joint. The company developed it using proprietary 3D printing technology that it claims has an enhanced porous surface which resembles the trabecular structure of cancellous bone.
iFuse-3D, with its trabecular-like surface, provides 250% greater surface area than an earlier product, iFuse Implant. The structural fenestrations allow complete bone through growth.