The US Food and Drug Administration (FDA) has awarded a 510(k) clearance to SI-Bone’s iFuse TORQ TNT Implant System (TNT) for treating pelvic fragility fractures.
The TNT implant is designed to improve early fixation and reduce the rate of screw backout. Thereby, proving a “more effective” treatment of pelvic fragility fractures than cannulated screws, the current standard of care.
“The current smooth stainless steel cannulated screws we are using in the pelvis were designed decades ago for fixing hip fractures. When trauma surgeons began modernising their techniques for pelvic fracture fixation, they simply started using longer screws,” said Charles Moon, director of orthopaedic trauma at Cedars-Sinai Hospital.
“Numerous clinical studies have shown significant issues with this strategy, especially in the geriatric population. Screw loosening can cause pain, which can slow a patient’s progress postoperatively and may require a second surgery. As surgeons, we really want to avoid second surgeries in the elderly. With TNT, there is now a system designed specifically for the sacropelvic anatomy that may reduce the rate of screw backout in this patient population. The implant is accompanied by instrumentation to match modern surgical techniques.”
The TNT system is SI-Bone’s second orthopaedic implant to receive a 510(k) clearance this year. The company’s iFuse Bedrock Granite implant (Granite 9.5) was cleared for sacroiliac fixation in January 2024.
SI-Bone has seen considerable growth in sales for its products. Last year, its global revenue increased by 31% to $138.9m, mainly driven by US sales growth of 32%. In August 2024, the company adjusted its 2024 worldwide revenue guidance to between $165m and $167m, suggesting a year-over-year growth of 19%-20%.
GlobalData expects the market for orthopaedic devices is grow from being worth approximately $53.9bn in 2024 to more than $70.4bn by 2030. The hip reconstruction segment is also expected to share in the market boom and expand from being worth approximately $8bn in 2024 to over $10.6bn by 2030.
There have been multiple developments in pelvic fixation implants to accommodate the varied patient needs. In February 2023, CurvaFix introduced a new 7.5mm intramedullary device to simplify surgery and enable stable fixation in small-boned patients. The implant is expected to offer potential benefits in different pelvic injuries and conditions, including polytrauma patients who have multiple complex injuries, FFP [fresh frozen plasma] patients with weak bone and those with dysmorphic bony anatomy.
