CurvaFix Receives FDA 510(k) Clearance for CurvaFix Rodscrew

By Julie A. Vetalice

CurvaFix received FDA 510(k) clearance to market the CurvaFix® Intramedullary Rodscrew for pelvic trauma surgery.

The flexible device is implanted through a small incision into the intramedullary space, then converted into a rigid state to stabilize and repair the fracture. The CurvaFix Rodscrew is reportedly the only intramedullary implant capable of following the natural bone shape of curved bones, such as the pelvis.

“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,” said Steve Dimmer, CEO for CurvaFix.

Founded in 2013, CurvaFix has raised a total of $2.5M in funding over two rounds to date, with the latest occuring in 2018.

Source: CurvaFix, Inc.

Product Labels: Lower Extremity

Tags: 510(k) Clearance, Regulatory