Medicrea said it won 510(k) clearance from the FDA for its UNiD device, billed as the world’s 1st patient-specific spinal osteosynthesis rod.
The UNiD system’s software allows surgeons to order rods customized to fit the specific spinal alignment needs of each patient, New York & Lyon, France-based Medicrea said. Surgeons often have to manually contour rods during surgery, which can increase the amount of time patients spend in surgery, according to the company.
The customized rods also allow surgeons to better plan their operations in advance, which can boost surgical success rates and improve patient outcomes, according to a press release.
Surgeons implanted the UNiD rod into the 1st U.S. patient Nov. 10. More than 100 patients have received the device in Europe, according to the company.
Medicrea said plans to unveil the technology this week at the annual meeting of the North American Spine Society in San Francisco.