FDA Approves 3D-Printed Titanium Pelvic Implant

For the millions of people who could benefit from medical implants, 3D printing technology holds considerable promise.

The latest step forward toward the widespread use of custom 3D-printed medical implants came on Tuesday, when it was announced that a 3D-printed titanium implant had been approved for use in the United States by the Food and Drug Administration (FDA).

The approval was for the iFuse-3D Implant, which is designed to address problems of the sacroiliac (SI) joint, located between the ilium and sacrum bones on either side of the pelvis. The sacrum gives the spine support and the ilium gives support to the sacrum. The iFuse-3D is just the latest edition in a series of iFuse implants.

SI-BONE, the company behind the iFuse implant suite, said it created a novel 3D printing innovation to be able to make the new implant, which features a refined porous exterior and perforated design. Both of these characteristics help to promote therapeutic bone growth and targeted bone fusion. The iFuse is based on a triangular design that has already been used in more than 26,000 procedures and endorsed by greater than 50 peer-reviewed publications, the company noted in a press release.

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. iFuse-3D...  provides 250 percent greater surface area than our highly successful iFuse Implant.  Additionally, the structural (perforations) allow complete bone through growth.

Scott Yerby, SI-BONE’s Chief Technology Officer

Titanium has already been used to make a number of 3D-printed medical implants, including vertebrate and jaw implants. However, only 3D-printed cranial/craniofacial implants and a digital fusion implant made with titanium has been approved by the FDA thus far.

The new iFuse-3D was developed to address SI joint issues, which can cause pain from the lower back to the upper legs while standing up, walking, lifting, sleeping, using stairs or sitting on the afflicted side. Doctors have ascribed this joint to pain in 15 to 30 percent of people with persistent lower back pain, and in as many as 43 percent of patients who have new or continuing lower back pain after lumbar fusion. Sadly, this pain is often wrongly diagnosed, with patients and healthcare providers typically overlooking the SI joint as the cause.

The new FDA approval comes on the heels of another 3D-printed medical implant development by a team from the University of Florida. Last month, a UF team announced a breakthrough method for 3D-printing technology that could lead to markedly faster implantation of devices that are more robust, more affordable, more versatile and more comfortable than similar implants available today.In a recently released study published by the International Journal of Spine Surgery, the team that developed the new iFuse implant showed substantial bone growth on and into the 3D printed implant’s highly-permeable surface, and through its perforations. Moreover, the implant enables a smaller incision size, less soft tissue stripping, and minimal tendon irritation compared to other implants. However, there are some likely risks linked with the system, like infection, sensitivity and implant rejection.

The technique involves the 3D printing of pliable silicone to produce medical implants used by a massive amount of people, including restrictive bands, slings, supportive meshes and those used to drain fluids. The current process to develop these implants requires moulding, which means patients may have to wait days or weeks for the implant to be ready. The new 3D printing method developed by the Florida team can print the same devices in mere hours.

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