Centinel Spine has received certification under the European Union (EU) Medical Device Regulation (MDR) for its prodisc C Vivo and prodisc C Nova cervical total disc replacement (TDR) systems.
The company has completed the necessary registration and certification process for these TDR products, ensuring compliance with the latest regulatory requirements.
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They are now CE-marked, indicating their adherence to high European standards. Both devices have been in clinical use globally since 2009.
The prodisc C Vivo features keel-less insertion and an anatomically designed superior endplate with lateral spikes for optimal fit and immediate fixation.
In contrast, the prodisc C Nova includes a flat endplate that aligns with flat vertebral anatomy and a tri-keel design that also provides immediate fixation.
Each device utilises prodisc CORE technology, which has contributed to the predictable clinical outcomes observed in over 275,000 implantations across more than 35 years.
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By GlobalDataCentinel Spine CEO Steve Murray said: “Securing MDR certification for the prodisc C Vivo and prodisc C Nova total disc replacement devices has been a complex and demanding process, but it underscores our commitment to delivering safe, high-quality, and clinically proven products.
“A fundamental pillar of our strategic vision is to improve the lives of as many patients as possible worldwide by expanding access to prodisc technologies. Achieving MDR certification represents a critical milestone in realising that vision.”
Centinel Spine focuses exclusively on developing solutions for cervical and lumbar spinal diseases.
In 2023, Switzerland-based Silony Medical International acquired Centinel Spine’s global fusion business to enter the US spinal fusion market.
