Arthrosurface said yesterday that it received FDA 510(k) clearance for its Boss toe fixation system, which the company believes will be commercially available at the end of the month.
The Franklin, Mass.-based company said the Boss system is designed to improve stabilization in the first metatarsal with a distal bone void and to provide patients with a motion-preserving alternative to standard to toe fusion. The device may also fill the void of treatment options for patients with failed synthetic implants, the company said.
The Boss system will be unveiled at the Arthrosurface booth during the American Orthopaedic Foot & Ankle Society annual meeting from Sept. 12-15 in Chicago, then will be available by the end of September.
“Finally there is an option other than fusion for failed synthetic implants,” said Dr. Carl Hasselman, an orthopedic surgeon with the University of Pittsburgh Medical Center, said in the release. “We can preserve motion of the joint, even in these difficult cases where there is a defect or void in the bone.”
“We developed this device so we could meet the healthcare needs of our patients,” added Dr. Michael Downey and Dr. Gregory Jaryga, foot and ankle surgeons with Trinity Foot & Ankle Specialists in Texas. “Many experienced adverse effects from other toe implants or fusion plate systems. After much research and the gathering of qualitative data, we are confident in the future success of this device to fulfill patients’ needs.”