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The regulatory nod expands Si-Bone’s iFuse-TORQ’s indication for acute, non-acute and non-traumatic pelvic fractures, including pelvic fragility fractures (fractures related to low-energy traumatic events) and pelvic insufficiency fractures.

Santa Clara, California-based Si-Bone said in a news release that the options for the iFuse-TORQ represent a market opportunity totaling approximately $300 million.

“Many elderly patients with sacral fragility fractures require long periods of immobility while their fracture heals, often leading to complications associated with bed rest,” Dr. Michael Gardner, Chief of Orthopedic Trauma at Stanford University Hospital, said in the release. “A paradigm shift is required. The strength and osseointegrative features of iFuse-TORQ make it the most attractive implant on the market to remobilize these osteoporotic patients.”

The iFuse-TORQ’s new indications for fracture fixation of the pelvis adds to its already existing indication for the fusion of the sacroiliac joint for sacroiliac joint dysfunction, including sacroiliac joint disruption and degenerative sacroiliitis.

“Since its launch in 2021, iFuse-TORQ has been used to treat many patients suffering from a pelvic fracture or sacroiliac joint dysfunction,” Si-Bone CEO Laura Francis said. “This pelvic fracture fixation indication expansion comes on the coattails of the iFuse Bedrock Granite launch and expands Si-Bone’s position as the market leader in the sacropelvic space.”

Filed Under: 510(k), Food & Drug Administration (FDA), Implants, Orthopedics, Regulatory/Compliance Tagged With: Si-Bone

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