First 3D Printed Titanium Implant for the Sacroiliac Joint, the iFuse-3D Implant, Gets FDA Clearance

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.

Jeffrey Dunn, President and CEO of SI-BONE, said, “The iFuse-3D Implant embodies our commitment to advancing the diagnosis and treatment of chronic SI joint disorders through innovative products, procedures and educational programs in order to help patients suffering from chronic SI joint pain. Our team of almost 200 employees is incredibly excited to support the more than 1,300 surgeons who have used the iFuse Implant, and we believe that expanding the iFuse family has the potential to help thousands more patients. What can be more exciting and rewarding than that?”

Patients who have SI joint dysfunction often feel pain in the buttocks, lower back, and/or legs, especially while switching from sitting to standing, walking, bending and lifting, sleeping, stepping up or down, and sitting on the affected side. Doctors have attributed this joint as a source of pain for 15-30% of patients with chronic lower back pain, and in up to 43% of patients who have new onset or continuing lower back pain after lumbar fusion. Unfortunately, the pain is often misdiagnosed, as most patients don’t know to ask about the SI joint and not all healthcare providers evaluate it.

The iFuse Implant System, which received 510(k) FDA clearance in 2008 and CE approval for European commercialization in 2010, fuses the SI joint, in an MIS solution, by using its patented titanium implants to make an interference fit within the sacrum and the ilium. The triangular shape and press fit insertion technique minimize the SI joint’s nutation motion, in order to provide immediate fixation. This system is the only commercially available SI joint fusion device in the US that has published prospective clinical evidence, from different studies, that demonstrate improved patient function, quality of life, and pain.

SI-BONE’s new iFuse-3D Implant’s fenestrated structure and surface were specifically designed to promote intra-articular fusion and offer enhanced osteointegration. In a recently published study in the International Journal of Spine Surgery (IJSS), titled “Fortifying the Bone-Implant Interface: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants,” you can see significant bone growth on and into the 3D printed implant’s porous surface, and through its fenestrations; co-authors of the study include Regina F. MacBarb, PhD; Derek P. Lindsey, MS; Shane A. Woods, MS; Peggy A. Lalor, PhD; Mukund I. Gundanna, MD; and Scott A. Yerby, PhD.

“The design and development of the iFuse-3D implant was a multi-year effort,” explained Yerby, the Chief Technology Officer at SI-BONE. “Our goal was to expand the iFuse family using 3D-printing technology to provide enhanced surface characteristics while retaining key performance features of the iFuse Implant, including superior rotational resistance, mechanical strength and ease of use with our existing instrumentation. iFuse-3D, with its trabecular-like surface, provides 250% greater surface area than our highly successful iFuse Implant. Additionally, the structural fenestrations allow complete bone through growth.”

The iFuse Implant System is only intended for sacroiliac fusion in conditions such as sacroiliac joint dysfunction, a result of degenerative sacroiliitis and sacroiliac joint disruption. This does include conditions where the symptoms began during pregnancy, or in the peripartum period, and have continued for over six months postpartum. It allows for a smaller incision size, less soft tissue stripping, and minimal tendon irritation, but there are some potential risks associated with the system, such as infection, metal sensitivity, and implant rejection, so always discuss with your doctor first. The patent for the iFuse-3D Implant from the US Patent and Trademark Office covers some of its structural design features, and offers intellectual property protection until September 2035. Discuss in the SI-BONE forum at 3DPB.com.