TAMPA, Fla. — OSSIO Inc. has launched its OSSIOfiber Minimally Invasive All-natural Bunion Correction System, introducing a new approach to bunion surgery designed to simplify procedures for surgeons while improving recovery and outcomes for patients.
The system uses beveled, threaded, trimmable fixation nails made from OSSIOfiber, a bio-integrative, metal-free material that is designed to gradually become part of the patient’s natural bone as healing occurs. The company said the implant typically fulfills its fixation role over about two years before fully integrating into the body, leaving no permanent hardware behind.
The new bunionectomy system was showcased this week at the annual meeting of the American College of Foot and Ankle Surgery in Las Vegas. In addition to the fixation nail, the system includes a streamlined instrument set that allows surgeons to trim and shape the implant during surgery to ensure a customized fit for each patient’s anatomy.
Steven K. Neufeld, M.D., founder of the Orthopaedic Foot & Ankle Center in Falls Church, Va., performed one of the first bunion procedures using the system and said the approach represents a significant advance in minimally invasive foot and ankle surgery.
“For my patients who need a bunionectomy, I offer treatment with the OSSIOfiber MIA Bunion Correction System,” Neufeld said. “This approach represents the pinnacle of minimally invasive foot and ankle surgery and signifies a significant advance in bio-integrative bunion repair. That’s how you elevate outcomes!”
Neufeld, who published the first U.S.-based study on minimally invasive bunion surgery in 2021, said incorporating bio-integrative implants into his practice has further improved results by eliminating the need for permanent metal hardware and reducing risks such as tissue irritation and secondary removal surgeries.
He recently presented data from a case series evaluating the use of OSSIOfiber implants in minimally invasive bunion surgery. In a group of 18 patients with an average age of 60, the procedures resulted in significant corrections, with patients returning to normal activity within six weeks. Osseous union was confirmed by 26 weeks, and no hardware removals or revision surgeries were reported.
The OSSIOfiber threaded trimmable fixation nails are indicated for maintaining alignment and fixation in a range of orthopedic procedures involving fractures, osteotomies, arthrodesis, and bone grafts in the upper extremity and lower limb, including the foot and ankle, in both adult and pediatric patients when appropriate immobilization is used.
OSSIO Chief Executive Officer Brian Verrier said the system reflects the company’s focus on patient-centered, metal-free orthopedic solutions.
“Our new OSSIOfiber Minimally Invasive All-natural Bunion Correction System gives the acronym a double meaning,” Verrier said. “The patient’s bunion goes missing, just like the implant itself. After the metal-free nail vanishes through bio-integration, patients go from missing in action to back in action. They walk away with their natural anatomy intact and no concerns about metal left in their body.”
Bunions, also known as hallux valgus, are a common foot condition caused by misalignment of the joint at the base of the big toe. The condition often worsens over time and can lead to pain, stiffness, redness, and swelling, particularly during standing and walking. The prevalence of bunions increases with age and affects roughly one-third of adults in the United States, according to federal health data.
