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The first patients will be treated with Si-Bone’s pelvic fracture fixation device

The first patients will be treated with Si-Bone’s pelvic fracture fixation device

Si-Bone’s TNT implant system is specifically designed for sacropelvic anatomy. Photo credit: Pitchayaarch Photography via Shutterstock.

US-based orthopedic company Si-Bone has announced that the first patients have been treated with its iFuse TORQ TNT Implant System (TNT).

Described as a breakthrough by the US Food and Drug Administration (FDA), the device is used to treat pelvic fragility fractures and is designed to improve early fixation and reduce the rate of screw back-out, making it a more effective treatment compared to cannulated screws, the current one Standard of care, makes .

Cannulated screws were originally developed for hip fractures and can cause problems, particularly in older patients. These may include problems such as screw loosening and the need for additional surgery. TNT is specifically designed for sacropelvic anatomy and to improve patient outcomes as loosening screws can cause pain.

Dr. JD Black from Kadlec Regional Medical Center, who performed one of the first procedures, said: “The optimized instrumentation and implant design not only provided excellent fixation, but also enabled rapid and precise implantation.” This efficiency is in the treatment of patients with brittle bones is crucial as it shortens operation time, minimizes risks and leads to faster recovery.”

The TNT implant received 510(k) clearance in August 2024, adding a second clearance to Si-Bone’s portfolio this year. The company’s iFuse Bedrock Granite implant (Granite 9.5) was released for sacroiliac fixation in January 2024.

Laura Francis, CEO of Si-Bone, said: “This breakthrough technology represents a significant advance in addressing the unmet clinical need of complex pelvic fragility fractures.” By providing a solution that improves both surgical efficiency and patient recovery, “We are continuing to expand our leadership position in the sacropelvic area.”

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According to Si-Bone, TNT is the first 3D printed transiliac-transsacral screw approved for market in the United States. However, there are other companies innovating in this area, including CurvaFix. The 7.5mm CurvaFix IM implant is designed to simplify surgical procedures and provide strong and stable curved fixation of pelvic fractures in smaller patients. The company secured $39 million in Series C funding in July 2023 to expand treatment for patients with pelvic fragility fractures across the United States.

According to GlobalData, the orthopedic devices market will grow from a value of around $53.9 billion in 2024 to over $70.4 billion in 2033. 3D printing in orthopedic implants is one of the top orthopedic device market trends emerging in 2023, according to GlobalData medical device analyst Tina Deng, MSc.