New FDA Clearance for CurvaFix Intramedullary Implant - CurvaFix

New FDA Clearance for CurvaFix Intramedullary Implant

FULL ARTICLE
Used with permission of ORTHOWORLD, Inc.

by Julie A. Vetalice

CurvaFix received FDA 510(k) clearance to market a smaller-diameter CurvaFix® Intramedullary Implant indicated for fixation of fractures of the pelvis. The new 7.5mm device is designed to provide strong, stable, curved fixation in smaller patients.

Clinical case reports have indicated that the CurvaFix IM Implant achieves strong, stable fixation that follows and fills the natural curvature of each patient’s anatomy, which may immediately reduce pain, allow for earlier mobility and improve patient recovery. The system has been shown to address many pelvic fracture fixation challenges, and enable surgeons to address challenges of fragility fractures of the pelvis in geriatric patients.

“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,” said Steve Dimmer, chief executive officer. “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.”