Medicrea’s Custom Spinal Rods Get FDA Green Light
French devicemaker Medicrea Group said Tuesday it has received 510(k) clearance for the UNiD patient-specific spinal osteosynthesis rod. The device is the first patient-specific product cleared for the treatment of degenerative spine conditions such as scoliosis and other deformities, a $2 billion market in the U.S. alone, according to the company.
The first U.S. patient was implanted with the UNiD rods in New York on Tuesday. The rods have been successfully implanted in more than 100 patients in Europe, Medicrea says.
The device features user-friendly software that helps surgeons plan surgery and design and order custom rods from Medicrea’s UNiD Lab to fit the specific spinal alignment needs of each patient. Surgeons don’t need to manually contour a rod during surgery, reducing the amount of time patients spend in the OR and the risk of infection, the company says.
The UNiD system also helps prevent postoperative rod breakage, which can occur in patients with severe spine deformities. The universal rods are available in two alloys, titanium and chromium, and in diameters of 5.5 mm and 6 mm. — Kellen Owings
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