Carlsmed, Inc., a MedTech company specializing in AI-driven personalized spine surgery, today announced that it has received FDA 510(k) clearance for the aprevo® Cervical ACDF Interbody System. This achievement highlights Carlsmed’s dedication to advancing patient-specific spine surgery solutions aimed at improving outcomes and enhancing surgical precision.
The FDA had previously granted Breakthrough Device designation to Carlsmed’s aprevo® technology for treating cervical spine disease, recognizing its potential to address unmet clinical needs and deliver superior care to patients. Currently, Carlsmed’s portfolio of aprevo® interbody fusion devices for treating lumbar spine disease is already commercially available in the U.S., and the FDA clearance for the cervical device expands the company’s reach in the personalized spine surgery market.
“This 510(k) clearance is a major step forward in our mission to make personalized spine surgery the standard of care,” said Mike Cordonnier, Chairman and CEO of Carlsmed. “With over 350,000 cervical fusion surgeries performed annually in the U.S., the aprevo® Cervical ACDF Interbody System will raise the bar in improving patient outcomes for these surgeries.”
The aprevo® Cervical ACDF Interbody System is designed with the goal of tailoring spine surgery to each patient’s unique anatomy and procedural needs. Personalized interbody devices, such as the aprevo® system, have shown to significantly improve patient outcomes compared to traditional one-size-fits-all fusion devices. Recent clinical studies have highlighted the benefits of customized spine fusion devices, which can lead to better healing, reduced complications, and enhanced overall recovery.
The technology behind the aprevo® system is based on Carlsmed’s proprietary platform, which combines AI-driven surgical planning software with advanced digital manufacturing techniques. This system enables the creation of personalized fusion devices that are custom-tailored to each patient’s specific spinal anatomy. One of the most innovative aspects of the aprevo® system is its ability to deliver these personalized devices in under two weeks, providing a faster solution for surgeons and patients alike.
Joseph Osorio, MD, PhD, a neurosurgeon at UC San Diego, commented on the importance of personalized interbody devices like aprevo®. “Having this technology available for cervical fusions is a significant step forward in spinal surgery,” Dr. Osorio explained. “By moving beyond the limitations of traditional implants, personalized devices offer enhanced surface coverage and more precise alignment. These features are critical for improving patient outcomes and transforming the way spinal procedures are performed.”
Looking ahead, Carlsmed plans to commercially launch the aprevo® Cervical ACDF Interbody System in the U.S. in 2025, further expanding its portfolio of personalized spine surgery solutions. This move is set to solidify the company’s leadership in the rapidly growing personalized spine surgery market, which continues to gain traction as more healthcare providers recognize the benefits of customized treatments.
About Carlsmed
Carlsmed is a high-growth medical technology company pioneering the personalized spine surgery market. The company’s mission is to revolutionize spine surgery by providing cutting-edge solutions tailored to the unique needs of each patient. Carlsmed’s aprevo® Technology Platform combines proprietary AI-driven software with patient-specific fusion devices, enabling more precise surgical procedures, improving patient outcomes, and reducing complications. With a focus on innovation and personalized care, Carlsmed is setting new standards in spine surgery.
