Medical Device Network

First patients are treated with Si-Bone’s pelvic fracture fixation device

Si-Bone’s TNT implant system secured 510(k) clearance from the US Food and Drug Administration (FDA) in August 2024.

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

The US Food and Drug Administration (FDA) breakthrough designated device is used to treat pelvic fragility fractures and is designed to improve early fixation and reduce the rate of screw backout, making it a more effective treatment compared to cannulated screws, the current standard of care.

Cannulated screws were originally designed for hip fractures and can cause issues – particularly in elderly patients. These can include issues such as screw loosening and the need for additional surgeries. TNT is specifically designed for sacropelvic anatomy and to improve patient outcomes, as screw loosening can cause pain.

Dr. J.D. Black of Kadlec Regional Medical Center, who performed one of the first procedures, said: “The streamlined instrumentation and implant design not only provided excellent fixation but also allowed for quick, precise implantation. This efficiency is critical when treating patients with fragile bones, as it reduces operating time, minimises risks, and leads to faster recovery.”

The TNT implant secured 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 cleared for sacroiliac fixation in January 2024.

Laura Francis, Si-Bone’s CEO said: “This breakthrough technology marks a significant step forward in addressing the unmet clinical needs of complex pelvic fragility fractures. By providing a solution that improves both surgical efficiency and patient recovery, we are further expanding our leadership in the sacropelvic space.”

Si-Bone said TNT is the first 3D-printed transiliac-transsacral screw cleared for market use in the US. However, there are other companies innovating in the space, including CurvaFix. Its 7.5mm CurvaFix IM Implant has been designed to simplify surgery and offer strong and stable curved fixation of pelvis fractures in smaller patients. The company secured $39m in Series C financing in July 2023 to expand the treatment for patients with pelvis fragility fractures across the US.

According to GlobalData, the market for orthopaedic devices is set to grow from being worth approximately $53.9bn in 2024 to more than $70.4bn by 2033. 3D printing in orthopaedic implants is one of the top orthopaedic device market trends that emerged in 2023, according to GlobalData medical device analyst Tina Deng, MSc.