Startup CurvaFix said it has landed FDA 510(k) clearance for a device to aid orthopedic trauma surgery.
The CurvaFix intramedullary rodscrew is a flexible device that is implanted through a small skin incision into the intramedullary space (center of the bone) and then converted into a rigid state to stabilize and repair a bone fracture. Bellevue, Wash.-based CurvaFix described its rodscrew as the only intramedullary implant capable of following the natural bone shape of curved bones such as the pelvis.
Pelvic fractures, often caused by car accidents or falls, are among the most serious and technically complex injuries treated by orthopedic surgeons. Stabilizing and repairing the bone to enable appropriate healing is a process called fixation. Existing pelvic fracture fixation methods can require lengthy, complex surgery and can sometimes result in suboptimal bone stabilization. This can slow recovery, cause ongoing pain, and may contribute to long-term disability.
The idea for the CurvaFix germinated when the former division head of orthopedic trauma at the University of British Columbia, Robert Meek, M.D., came to believe there was a better way to repair pelvic fractures. The company consulted with several orthopedic surgeons over the past four years to develop the rodscrew, according to CurvaFix CEO Steve Dimmer.
“We believe surgeons will welcome an implantable device that adapts to the patient’s own bone curvature and we anticipate that the CurvaFix rodscrew will improve fixation, shorten surgeries and reduce care costs,” Dimmer said in a prepared statement.