Centinel Spine Wins FDA Nod for 2-Level Disc Replacements

Centinel Spine has earned U.S. Food and Drug Administration (FDA) premarket approval (PMA) for 2-level indications for its prodisc C Vivo and prodisc C SK cervical total disc replacement (TDR) devices.

The two device received FDA approval for 1-level indications in July 2022. Since then, the company said almost 20,000 prodisc C Vivo and prodisc C SK spinal levels have been implanted in the U.S. by more than 1,100 surgeons.

Armen Khachatryan MD, Orthopedic Spine Surgeon at The Disc Replacement Center in Salt Lake City said the FDA approval for 2-level indications is an exceptional day for cervical arthroplasty.

“I am thrilled to witness the culmination of our efforts in the prodisc C Vivo and prodisc C SK clinical trial for two-level indications, resulting in FDA approval,” Dr. Khachatryan told the press. “I am particularly enthusiastic about integrating the distinct endplate configurations of the prodisc devices into my clinical practice. This approval expands the range of treatment options available to patients and underscores the continuous evolution and refinement of motion-preserving surgical techniques for cervical spine disorders.”

To gain approval, a 480 subjects were enrolled in the investigational device exemption (IDE) study at 31 centers, and the PMA is based on analysis of 433 subjects. Centinel Spine said this is the highest number of subjects used to support a PMA for any cervical TDR device on the market. The study was also the first of its kind to evaluate two investigational TDR devices and the first PMA based on an IDE study  that compared an investigational system to a PMA approved cervical TDR device.

The prodisc C Vivo has been in clinical use internationally since 2009 and is currently one of the most frequently implanted TDR devices in the world. The device offers keel-less insertion and combines a unique anatomically-designed superior endplate with lateral spikes to optimize fit and provide immediate fixation.

The prodisc C SK device features a flat endplate designed for optimized implant positioning that allows surgeons to address individual patient anatomy—with a low-profile central keel that offers immediate fixation and enables a streamlined keel preparation technique.

“This is a historic milestone for Centinel Spine and further advances treatment options for spine surgeons and their patients,” said Centinel Spine CEO Steve Murray. “The IDE trial supporting this FDA approval is a landmark study using another FDA-approved disc device as a control and including two different investigational devices that could be used for the same patient. This 2-level approval advances the concept of uniquely matching the disc to each level of the patient’s cervical spine and is a major step forward in total disc replacement.”