Orthofix FIREBIRD SI Fusion System Receives Additional FDA Clearance for Nanotechnology

October 1, 2020

Orthofix Medical Inc today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the nanotechnology feature of the FIREBIRD SI Fusion System. Introduced earlier this year, the FIREBIRD SI Fusion System is the first 3D-printed titanium bone screw with nanotechnology specifically designed to compress and stabilize the sacroiliac joint (SI joint) during fusion.

“The FIREBIRD SI Fusion System with NANOVATE technology is one of the many new differentiated solutions that Orthofix is proud to highlight during the upcoming North American Spine Society (NASS) 2020 virtual annual meeting,” said Kevin Kenny, Global President of Orthofix Spine. “The clearance of the nanotechnology feature gives us the opportunity to educate surgeons about the unique benefits of the system’s nano-surface. Created through a proprietary manufacturing process, the FIREBIRD SI Fusion System is the result of our intense focus on bringing innovations to the market to enable surgeons to meet the needs of their patients.”

The FIREBIRD SI Fusion System is implanted through a minimally invasive procedure that involves inserting two to four bone screws across the SI joint to stabilize the joint during the fusion process. The system’s 3D-printed mid-shaft porous region is designed to allow for bone through growth through the device to aid in the fusion process for patients being treated for pain and dysfunction of the SI joint.”

Featuring a cannulated screw design, the system enables surgeons to pack the device with autograft and/or allografts to help promote bone fusion. The FIREBIRD SI screws are available in an assortment of lengths and diameters to address a variety of patient anatomies. Orthofix offers allograft solutions such as the Trinity ELITE allograft with viable cells through a partnership with MTF Biologics.

Common causes that may lead to SI joint dysfunction and pain include trauma, lifting or twisting, pregnancy, natural childbirth, degeneration from previous lumbar spine surgery, stresses to the joint due to leg length differences, joint replacement or scoliosis among others. Published clinical literature indicates that sacroiliac joint pain is estimated to affect between 15 and 30 percent of individuals with chronic low back pain.

 

Hot this week

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”

Avery Dennison Medical Introduces Ipdated SilFoam Lite: Sustainability, MDR Certification & Performance Improvements

The newly enhanced SilFoam Lite delivers superior efficiency and reliability, bringing improved fluid handling capabilities and improved tack. These improvements make the product ideal for customers seeking quality, high-performance solutions in wound care notes Avery Dennison Medical.

Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

Medtronic plc voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump's built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump

Medtronic Expands AiBLE Spine Surgery Ecosystem with New Technologies and Siemens Healthineers Partnership

New advancements in the AiBLE Spine Surgery ecosystem build upon the company's commitment to procedural innovation and execution