CurvaFix receives FDA 510(k) clearance for small-diameter pelvic fracture fixation implant
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CurvaFix Inc. received FDA 510(k) clearance of its CurvaFix IM implant for fixation of pelvic fractures in smaller patients, according to a press release.
The CurvaFix implant is designed to address the common challenges surgeons face with pelvic fractures, such as dysmorphic sacra and curved superior rami, according to the release.
“With this latest FDA clearance, we are able to offer surgeons the CurvaFix implant in two diameters, 7.5 mm and 9.5 mm, and in lengths ranging from 90 mm to 180 mm,” Steve Dimmer, CEO of CurvaFix, said in the release. “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,” Dimmer said.
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