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Medical Devices / Submissions and Approvals

SI-Bone, Inc. Gains FDA Clearance of the iFuse-3D Implant

June 14, 2017

SI-BONE has received FDA clearance of the iFuse-3D Implant, which is a 3D-printed titanium implant for use in the SI joint.

The iFuse-3D is a triangular shaped minimally invasive surgical device indicated for fusion for certain disorders of the sacroiliac (SI) joint.

As an addition to the iFuse implant system portfolio, the device has a fenestrated design and enhanced porous surface that resembles the trabecular structure of cancellous bone. These two features provide an environment for bony ongrowth, ingrowth and through growth.

The iFuse-3D implant has intellectual property protection for 17 years, until September 2035. — Cynthia Jessup

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