Medicrea Receives FDA 510(k) Clearance for Patient-Specific UNiD Cervical Rod

By Julie A. Vetalice

Medicrea received FDA clearance to market what is reported to be the first-ever patient-specific cervical rod for spine surgery, the UNiD™ Cervical rod, which is secured by the PASS OCT® posterior cervical stabilization system.

UNiD Lab personalized spinal alignment services are now available to cover the cervical, thoracic and lumbar spine. Devices are custom-designed to match the rod's shape with the patient's spinal alignment and surgeon's pre-op plan; post-op, UNiD Lab provides analysis of the procedure and the surgeon’s case series, including a comparison with normative data to provide data analysis to the surgeon and patient.

By eliminating the need to manually bend a rod, UNiD reportedly reduces OR time by 15-30 minutes. Further, the PASS OCT System is designed specifically to support UNiD by minimizing forces applied to the spine when securing the rod.

Medicrea's UNiD system received initial FDA 510(k) clearance in 4Q14; the system had launched in the EU earlier that year.

Sources: Medicrea; ORTHOWORLD Inc.

Product Labels: Cervical Spine

Tags: 510(k) Clearance, Regulatory