Sam Brusco, Associate Editor11.01.22
CurvaFix has gained U.S. Food and Drug Administration 510(k) clearance for its smaller-diameter (7.5 mm) CurvaFix IM (intramedullary) implant for fixation of pelvic fractures.
“With this latest FDA clearance, we are able to offer surgeons the CurvaFix Implant in two diameters, 7.5mm and 9.5mm, and in lengths ranging from 90mm to 180mm,” Steve Dimmer, CEO of CurvaFix told the press. “Surgeon feedback from our first year of commercialization has told us that a device for pelvic fractures in narrow, curved pelvic corridors was also needed. Both smaller high-impact trauma patients and petite fragility fracture patients should benefit from this new, sleeker, curved implant. This is a key milestone in our mission to simplify pelvic fracture fixation surgery for orthopedic trauma surgeons and to help patients mobilize soon after surgery.”
Clinical case reports have shown the CurvaFix IM implant achieves strong, stable fixation that follows and fills natural curvature of anatomy, which can reduce pain, allow for earlier mobility, and boost recovery. The system aims to simplify pelvic fracture fixation surgery with a fast, easy, repeatable, minimally invasive procedure.
The system has been demonstrated 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 in geriatric patients by providing strong fixation in weak bone with a minimally invasive procedure.
“With this latest FDA clearance, we are able to offer surgeons the CurvaFix Implant in two diameters, 7.5mm and 9.5mm, and in lengths ranging from 90mm to 180mm,” Steve Dimmer, CEO of CurvaFix told the press. “Surgeon feedback from our first year of commercialization has told us that a device for pelvic fractures in narrow, curved pelvic corridors was also needed. Both smaller high-impact trauma patients and petite fragility fracture patients should benefit from this new, sleeker, curved implant. This is a key milestone in our mission to simplify pelvic fracture fixation surgery for orthopedic trauma surgeons and to help patients mobilize soon after surgery.”
Clinical case reports have shown the CurvaFix IM implant achieves strong, stable fixation that follows and fills natural curvature of anatomy, which can reduce pain, allow for earlier mobility, and boost recovery. The system aims to simplify pelvic fracture fixation surgery with a fast, easy, repeatable, minimally invasive procedure.
The system has been demonstrated 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 in geriatric patients by providing strong fixation in weak bone with a minimally invasive procedure.