Carlsmed Receives FDA Clearance for aprevo® Cervical ACDF Interbody System

Carlsmed has received FDA 510(k) clearance for the aprevo® Cervical ACDF Interbody System, which was developed using Carlsmed’s proprietary technology platform that leverages AI-driven surgical planning software and digital manufacturing to create personalized spinal fusion devices that can be delivered in less than two weeks. Carlsmed plans to launch the aprevo® Cervical ACDF Interbody System in the U.S. in 2025, further expanding its innovative product portfolio and solidifying its leadership in the personalized spine surgery market.

The FDA previously granted Carlsmed’s aprevo® technology Breakthrough Device Designation for the treatment of patients with cervical spine disorders, recognizing aprevo’s potential to address unmet clinical needs and provide superior patient care. The company’s current portfolio of aprevo® interbody fusion devices for the treatment of lumbar spine disorders is commercially available in the US.

“More than 350,000 cervical fusion surgeries are performed annually in the U.S. The aprevo® Cervical ACDF Interbody System will set a new standard for improving outcomes for these patients,” said Mike Cordonnier, Chairman and CEO of Carlsmed. Joseph Osorio, MD, PhD, and neurosurgeon at UC San Diego, stated, “The availability of this technology for cervical fusions represents a significant advancement in spinal surgery with the potential to transform procedures by replacing the limitations of one-size-fits-all implants with level-specific customization that provides enhanced surface coverage and precise alignment, both of which are critical to improving patient outcomes.”