CurvaFix Secures FDA Clearance to Advance Pelvic Fracture Treatment

New low-profile system offers improved fixation, streamlined procedures and early mobility for patients with complex pelvic fractures

BELLEVUE, Wash.--(BUSINESS WIRE)--CurvaFix, Inc., a developer of medical devices to repair fractures in curved bones, today announced FDA 510(k) clearance for its next-generation CurvaFix® Low Profile System, a percutaneous solution for fixation of pelvic fractures. It is estimated that 200,000 pelvic fractures occur annually in the U.S., many of which require surgical intervention to restore stability, alleviate pain, and enable early weight-bearing and mobility, which are critical steps in helping patients return to their quality of life.

“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.”

“CurvaFix Low Profile advances surgeons’ ability to address surgical scenarios well beyond the reach of traditional hardware,” said Samir Mehta, M.D., Orthopaedic Trauma Surgeon. “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. The new platform takes CurvaFix technology to the next level, offering improvements that directly benefit both patients and surgeons.”

The CurvaFix Low Profile System is purpose-built to expand surgical options in challenging scenarios, including pathological bone, curved or narrow pelvic corridors, intersecting fixation pathways, and cases where indwelling or adjacent hardware is present. The new system offers:

• 65% smaller head geometry for a lower-profile construct
• Implants with increased compression capability
• Extended implant lengths up to 210mm, enabling connection of intraosseous fixation pathways with a single device
• Patented lock technology with improved visual and tactile confirmation

Clinical experience has shown that the CurvaFix technology provides strong, stable fixation that follows and fills the natural curvature of each patient’s anatomy. This unique approach may reduce pain, support earlier mobility, and improve recovery compared to conventional straight implants.

About CurvaFix, Inc.

CurvaFix, Inc. is a privately held medical device company headquartered in Bellevue, Wash. CurvaFix is developing implantable products to improve fracture repair in curved bones, with a focus on fragility fractures of the pelvis and high-energy pelvic trauma. The CurvaFix IM and CurvaFix Low Profile Systems have received 510(k) clearance from the U.S. Food & Drug Administration (FDA).