Titanium has been used to 3D print all sorts of items, like hearing aids and airplane parts, and even a Garmin cycle mount, but the metal is really making a difference in the medical field. We’ve seen 3D printed titanium vertebrae, spinal interbody devices, and every type of titanium implant you can imagine, from hip implants and jaw implants to a titanium mini-plate implant system used to fix a man’s drooping eye. As we know, it can be a challenge to receive FDA clearance for medical devices and medicine developed with 3D printing technology as 3D printers and medical regulations come into increasing focus. We have so far seen 3D printed titanium cranial/craniofacial implants and a 3D printed titanium digital fusion implant receive the coveted stamp of FDA approval. And today, California-based medical device company SI-BONE announced that it has joined the ranks of the FDA approved.
SI-BONE is dedicated to developing, manufacturing, and commercializing minimally invasive surgical (MIS) devices for patients with low back symptoms, and pioneered the use of its triangular MIS iFuse Implant System, which is used for fusion for certain disorders of the sacroiliac (SI) joint. This joint is between the ilium and sacrum bones on each side of the pelvis; the sacrum supports the spine, and the ilium supports the sacrum.
The company announced today that it has received FDA clearance for its patented iFuse-3D Implant, its next-generation member of the iFuse Implant System and the first 3D printed titanium implant for use in the SI joint. SI-BONE also announced the full commercial launch of the iFuse-3D in the US.
SI-BONE developed a proprietary 3D printing technology in order to develop the implant, which features an enhanced porous surface that resembles the trabeculur structure of cancellous bone and a unique fenestrated design; both of these features combine to make an environment that promotes bone ongrowth, ingrowth, through growth, and intra-articular fusion. It also leverages the triangular design of the iFuse Implant System, which is clinically proven after being used in over 26,000 procedures and supported by more than 50 peer-reviewed publicatons.
Image Credit: SI-BONE