CurvaFix has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation CurvaFix low-profile system, a percutaneous solution for fixation of pelvic fractures.

The company said the system was built to expand surgical options in difficult scenarios including pathological bone, curved or narrow pelvic corridors, intersecting fixation pathways, and cases where indwelling or adjacent hardware is present.

It features a 65% smaller head geometry for a low profile construct and implants with increased compression capability. Extended implant lengths up to 210 mm enable connection of intraosseous fixation pathways with a single device. Patented lock technology also allows improved visual and tactile communication.

Samir Mehta, MD, an orthopedic trauma surgeon, said CurvaFix low profile advances surgeons’ ability to address surgical scenarios well beyond the reach of traditional hardware.

“It has transformed how we manage these injuries, delivering exceptional outcomes, an excellent safety profile, and early weight bearing for patients facing these difficult fractures,” Dr. Mehta told the press. “The new platform takes CurvaFix technology to the next level, offering improvements that directly benefit both patients and surgeons.”

CurvaFix said clinical experience has demonstrated that its technology offers strong, stable fixation that follows and fills the curvature of each patient’s anatomy. The approach may reduce pain, support earlier mobility, and boost recovery compared to conventional straight implants.

“CurvaFix continues to revolutionize pelvic fracture fixation with the launch of our Low-Profile System,” said Mark Foster, CEO of CurvaFix. “This new system reflects four years of clinical use and thousands of successful implants, coupled with direct feedback from orthopedic trauma surgeons. The result is a familiar, intuitive implantation technique designed to address the complexities of pelvic fracture fixation, while also allowing streamlined implant removal if required.”