US-based medical devices developer CurvaFix has received the US Food & Drug Administration (FDA) 510(k) approval for its smaller-diameter CurvaFix IM Implant.
The updated intramedullary (IM) implant, with a lower diameter of 7.5mm, is indicated for fixation of fractures of the pelvis.
With the FDA approval, the company is now allowed to offer the implant in both 7.5mm and 9.5mm diameters, and in 90mm to 180mm length ranges.
The implant system enables simplified pelvic fracture fixation surgery with minimally invasive procedure, and offers a strong, stable, curved fixation in smaller patients, said the company.
CurvaFix chief executive officer Steve Dimmer said: “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 orthopaedic trauma surgeons and to help patients mobilize soon after surgery.”
CurvaFix IM Implant system is said to address various pelvic fracture fixation challenges, including dysmorphic sacra, and curved superior rami.
It also addresses the challenges of fragility fractures of the pelvis (FFP) in geriatric patients, through strong fixation in weak bone with a minimally invasive procedure.
According to clinical case reports, the implant system enables strong, and stable fixation as per the natural curvature of each patient’s anatomy, to reduce pain, allow earlier mobility, and improve patient recovery.
In October last year, CurvaFix has commercially launched the CurvaFix IM Implant for the fixation of pelvic and acetabular fractures.
Dimmer then said: “With the commercial launch of the CurvaFix Implant, we believe a new clinical standard will be set in orthopedic trauma surgery for pelvic fixation and repair.
“Our novel implantable device is the only intramedullary device capable of following the natural bone shape and filling the space within the pelvis.”
