Medtronic Gains FDA Clearance for UNiD Patient-Specific Rods with CD Horizon Solera Voyager and Infinity OCT

By Julie A. Vetalice

Medtronic Gains FDA Clearance for UNiD Patient-Specific Rods with CD Horizon Solera Voyager and Infinity OCT

Medtronic was granted FDA 510(k) clearance to market patient-specific UNiD™ Rods for use with its CD Horizon™ Solera™ Voyager™ and Infinity™ OCT spinal systems. Medicrea's UNiD Rods are industrially bent prior to surgery to accurately match an artificial intelligence (AI)-driven pre-operative surgical plan, which is created with UNiD Adaptative Spine Intelligence (ASI) technology to precisely align patients' spines. UNiD Rods are used to treat scoliosis, trauma, tumors and complex degenerative conditions in adults and adolescent idiopathic scoliosis.

Medtronic acquired Medicrea in 2020.

The combination of UNiD Rods and Medtronic's spinal systems allows surgeons to select the Medtronic interbody devices and other hardware of their choosing. Surgeons can also use navigation and robotics, like the Mazor™ Robotic Guidance System, with UNiD rods.

"By combining our widely used spinal systems with UNiD Rods, Medtronic is putting surgeons on the forefront and revolutionizing spine care as the first company to offer a fully integrated solution with unparalleled technologies - AI-driven surgical planning, personalized spinal implants and robotic assisted surgical delivery that work together to advance patient care," said Dan Wolf, Vice President, Medicrea, within the Cranial & Spinal Technologies business, which is part of the Neuroscience Portfolio at Medtronic.

UNiD ASI uses a database of thousands of surgical cases to power algorithms that visualize multiple permutations, allowing surgeons to better understand their patients' alignment before surgery, customize a surgical plan with UNiD™ LAB biomedical engineers and use a patient-specific rod industrially bent in the optimal plane to help ensure the goals of the surgery are achieved. AI helps visualize mechanisms above and below the spine that will most likely occur based on the surgical plan in order to enhance clinical and surgical workflow, increase reproducibility, improve surgical outcomes.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory