FDA clears Orthofix Firebird SI fusion system

June 29, 2020 By Sean Whooley Leave a Comment

Orthofix (NSDQ:OFIX) announced today that it received FDA 501(k) clearance for its Firebird SI 3D-printed titanium bone screw.

Lewisville, Texas-based Orthofix touts its Firebird SI as the first 3D-printed titanium bone screw to launch in the U.S. for treating sacroiliac (SI) joint dysfunction. The fusion system is designed to both compress and stabilize the SI joint, according to a news release.

The Firebird SI includes a porous mid-shaft region designed to allow bone to grow into its surface, creating a bond between the implant and the patient’s bone at the SI joint. With a cannulated screw design, surgeons can pack the device with autografts and/or allografts with viable cells to help ensure bone fusion.

Screws for the system are available at a variety of lengths and diameters and are implanted through a minimally invasive surgery that takes about one hour and may lead to less time at the hospital with faster recovery, Orthofix said.

The company is launching the novel system in the U.S. through a limited market release, having already seen Dr. Justin Hall of the Baptist Memorial Hospital-Golden Triangle (Columbus, Miss.) complete the first U.S. implant.

“Orthofix Spine prides itself in creating differentiated technology for the advancement of patient care,” Orthofix Spine global president Kevin Kenny said in the news release. “We are excited to bring the Firebird SI fusion system to market as an extension of our flagship Firebird line of devices. This new system is another example of our commitment to providing surgeons and their patients with innovative options that interface with products and solutions within our portfolio.”

What’s next for nitinol tubing?
Nitinol’s unique properties have made it the darling of the medical device industry. A novel technique for mechanically joining nitinol to other metal tubing could reduce cost and mitigate risk. Mark Broadley, Viant Nitinol has revolutionized the medical device industry. With its flexible superelasticity, shape memory and biocompatibility, nitinol has become a go-to material for… […]
Report: Haemonetics’ blood-collection devices could leave particles in donors
A consortium of news outlets is questioning the safety of Haemonetics (NYSE:HAE) blood-collection devices, claiming that particles have been detected in donors whose plasma was extracted by the machines. According to a report in the Miami Herald, whistleblower documents indicate that more than 150 Haemonetics customer reports have been made regarding the presence of particles by plasma collection centers and heathcare… […]
Spinal Elements’ cervical fixation system wins FDA nod
Spine surgery technology developer Spinal Elements announced today that it received FDA clearance for its Sapphire X product for anterior cervical fixation. Sapphire X is comprised of integrated instrumentation and high-angulation screws designed to help surgeons perform a procedure while preserving the patient’s skeletal and muscle tissue. The instrumentation is designed to reduce procedural steps… […]
How COVID-19 impacts FDA interactions with medical device manufacturers
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time. Get the full story here at the Emergo Group’s blog. The opinions expressed… […]
Switchback Medical adds ‘sandbox approach’ to device testing
Contract manufacturer Switchback Medical (Maple Grove, Minn.) today announced that it has added a new division. Switchback BioSim Innovations offers functional dynamic biosimulator model development, cell culture services and physician training, according to the company. Biosimulator models use animal and human tissue to create functional models, such as a pumping heart with working valves to… […]
Smith College team wins ventilator design challenge
A team of Smith College engineering alumnae, staff and faculty has won the CoVent-19 Challenge to design a rapidly deployable ventilator to address shortages caused by the COVID-19 pandemic, particularly in developing countries. A dozen anesthesiology resident physicians from Massachusetts General Hospital kicked off the public challenge April 1, attracting 200 entries. The 30-person team… […]
FDA gives certain device makers more time to add UDIs
The FDA said today that it will grant manufacturers of Class 1 and unclassified medical devices and certain others more time to add unique device identifiers (UDIs) to their products. These companies will now have until Sept. 24, 2022 to comply with the agency’s UDI rule, including standard date formatting, labeling and Global Unique Device… […]
Eurofins launches 10-minute COVID-19 exposure testing device
Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19. The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release. Get the full story at our sister site,… […]
How is RF technology shaping the future of medtech?
RF technology, including microwaves, isn’t just about wireless communications or military radar these days. Times Microwave Systems experts point out that it is increasingly important when it comes to medtech. Many medical electronics systems such as magnetic resonance imaging (MRI) systems for cancer detection rely on RF/microwave technology. Times Microwave Systems (Wallingford, Conn.) is hosting… […]
Medical device litigation and COVID-19: What you need to know
The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights. Sara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits. “I say,… […]
Mayo Clinic needed to engineer its way through COVID-19: Here’s what they did.
The health system’s medical and engineering staffs had to devise their own solutions for lab gear, PPE and operating room air decontamination. As COVID-19 settles into several regions of the U.S., healthcare systems that once sat on the sidelines likely will find themselves in the same situation as their counterparts in the Northeast did earlier… […]