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3D Printed Titanium Implant for Sacroiliac Joint Approved by FDA

3DPrint reports on a recent clearance by the FDA on SI-BONE’s patented iFuse-3D Implant, “its next generation member of the iFuse Implant System and the first 3D printed titanium implant for use in the sacroiliac joint.”

SI-BONE, a California-based medical device company, has “also announced the full commercial launch of the iFuse-3D in the US.”  The “triangular MIS iFuse Implant System…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.”

“SI-BONE developed a proprietary 3D printing technology in order to develop the implant, which features an enhanced porous surface resembling the trabecular structure of cancellous bone and unique fenestrated design; both of these features combine to make an environment promoting bone ongrowth, ingrowth, through growth, and intra-articular fusion.”

As Scott A. Yerby, Ph.D. and SI-BONE’s Chief Technology Officer, explains: “the design and development of the iFuse-3D implant was a multi-year effort.  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-3D Implant’s patent “covers some of its structural design features, and offers intellectual property protection until September 2035.”

Image and Quotes Courtesy of 3DPrint

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