CurvaFix, a developer of medical devices to repair fractures in curved bones, today announced it has received 510(k) clearance (K222505) from the FDA for its smaller-diameter CurvaFix IM Implant indicated for fixation of fractures of the pelvis. The new 7.5mm device is designed to simplify surgery and to provide strong, stable, curved fixation in smaller patients.
The CurvaFix IM system simplifies pelvic fracture fixation surgery with a repeatable and minimally invasive procedure. The system has been shown to address many pelvic fracture fixation challenges, including dysmorphic sacra, curved superior rami, and to enable surgeons to address challenges of fragility fractures of the pelvis (FFP) in geriatric patients by providing strong fixation in weak bone with a minimally invasive procedure.
