SI-BONE (SIBN) Receives FDA Nod for Its TNT Implant System

Company Overview - SI-BONE, Inc. has received FDA 510(k) clearance for its iFuse TORQ TNT implant system, which is the first anatomy-specific system designed for pelvic fragility fractures [1] - The TNT implant system is designed to address the specific anatomical and bone mineral density needs of the sacrum and ilium, featuring a porous threaded implant that spans the posterior pelvis [3] Product Details - The TNT system improves early fixation and reduces the rate of screw backout, potentially allowing for early patient weightbearing and mobilization [4] - TNT was previously awarded the Breakthrough Device Designation by the FDA, indicating its innovative approach to pelvic fragility fracture fixation and sacroiliac joint fusion [4] Market Insights - The global sacroiliac joint fusion market was valued at $721.2 million in 2023 and is expected to grow at a CAGR of 19.8% from 2024 to 2030, driven by increasing lower back pain prevalence and technological advancements [5] - Market growth is further supported by developments in minimally invasive surgical techniques and improvements in insurance coverage [6] Recent Developments - In May 2024, SI-BONE expanded its iFuse Bedrock Granite implant system portfolio with the launch of Granite 9.5, which received FDA 510(k) premarket clearance in January [8] - The Granite 9.5 is designed for patients with smaller anatomy and facilitates easier placement of stacked implants [8] Stock Performance - Shares of SI-BONE have decreased by 21.2% year-to-date, contrasting with the industry’s growth of 9.4% [8]