FDA Approves SI-Bone’s New Implant For Pelvic Fractures

 The FDA has granted 510(k) clearance to SI-Bone’s iFuse TORQ TNT Implant System (TNT) for addressing pelvic fragility fractures. This advanced implant aims to enhance initial fixation and minimize screw backout, offering a "superior" alternative to the traditional cannulated screws used in pelvic fracture treatment.

Charles Moon, Director of Orthopaedic Trauma at Cedars-Sinai Hospital, said that “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.”

He further added, “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.”

SI-Bone’s TNT system marks the company’s second orthopaedic implant to receive FDA 510(k) clearance this year. Following the January 2024 approval of the iFuse Bedrock Granite implant for sacroiliac fixation, SI-Bone has experienced significant growth, with global revenue climbing 31% to $138.9 million last year, driven largely by a 32% rise in US sales. In August 2024, SI-Bone revised its revenue forecast for 2024 to between $165 million and $167 million, indicating a projected growth of 19%-20% year-over-year.

The orthopaedic device market is anticipated to expand from approximately $53.9 billion in 2024 to over $70.4 billion by 2030, with the hip reconstruction segment also set to grow from around $8 billion to more than $10.6 billion in the same period. The field of pelvic fixation implants continues to evolve, as evidenced by CurvaFix's introduction of a new 7.5mm intramedullary device in February 2023, designed for easier surgery and stable fixation in patients with smaller bone structures.

This new implant from SI-Bone is expected to benefit a range of patients, including those with multiple complex injuries, those with weak bones due to fresh frozen plasma treatment, and individuals with dysmorphic bone anatomy. The original article, "FDA grants clearance for SI-Bone’s pelvic fixation system," was published by Medical Device Network, a GlobalData brand.