Carlsmed has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its aprevo cervical ACDF (anterior cervical discectomy and fusion) interbody system.

aprevo was previously awarded breakthrough status from the FDA to treat patients with cervical spine disease. Carlsmed’s portfolio of aprevo interbody fusion devices to treat lumbar spine disease is commercially available in the U.S.

Personalized interbodies are designed to match each patient’s unique anatomical and procedural requirements. These devices have shown improvements in outcomes compared to traditional methods of spinal fusion.

The company’s aprevo devices are designed using its proprietary platform that uses AI (artificial intelligence)-driven surgical planning software and digital production. This method builds personalized spinal fusion devices that Carlsmed said can be delivered in under two weeks.

“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. “More than 350,000 cervical fusion surgeries are performed annually in the U.S. The aprevo Cervical ACDF Interbody System will set a new benchmark for improving outcomes for these patients.”

The company expects to commercially launch the aprevo cervical ACDF system in the U.S. in 2025.

“Personalized interbody devices like aprevo provide surgeons with tools designed to address each patient’s unique anatomy,” said Joseph Osorio, MD, Ph.D., and neurosurgeon at UC San Diego. “Having this technology available for cervical fusions marks 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, offering enhanced surface coverage and precise alignment, both of which are critical for improving patient outcomes.”