Si-Bone wins FDA clearance, breakthrough nod for pelvic fixation implant

Si-Bone this week announced it received FDA 510(k) clearance and FDA breakthrough device designation for its iFuse Torq TNT Implant System.

The Santa Clara, California-based orthopedic company designed the TNT implant for pelvic fragility fracture fixation and sacroilliac joint fusion. TNT (through and through) is designed to meet the specific anatomical and bone mineral density needs of the sacrum and ilium.

“We are pleased the FDA recognized TNT as a Breakthrough Device. The number of people bedbound from pain related to pelvic fragility fractures is large and growing,” CEO Laura Francis said in a news release. “As the leader in the sacropelvic space we’re honored to be able to help surgeons get their frail and elderly patients back to mobility sooner, by providing the first anatomy-specific system designed to meet the biomechanical challenges presented by pelvic fragility fractures. After iFuse Bedrock Granite, which also was a Breakthrough Device, this is our second device to receive the designation. This highlights our ability to develop a platform of unique solutions that target large unmet clinical needs.”

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