FDA Approves Centinel Spine’s Two-Level prodisc L for Total Disc Replacement

By Julie A. Vetalice

FDA Approves Centinel Spine’s Two-Level prodisc L for Total Disc Replacement

Centinel Spine® received FDA Premarket Approval of two-level indications for the prodisc® L Lumbar Total Disc Replacement (TDR). They are now the only company in the world with an FDA-approved lumbar TDR device that has been clinically reviewed and found safe and effective for two-level use.

"The prodisc technology's remarkable safety and efficacy profile is a tribute to the design of the device," said CEO Steve Murray. "The longevity of the prodisc technology is due to the design principles of a stable bone interface, a consistent mechanism of action enabling guided motion, and instrumentation that facilitates efficient and reliable implantation."

The prodisc line now consists of six devices, including an anterior and anterior-lateral approach lumbar disc replacement and four cervical disc replacement implants. The line offers a variety of endplate configurations designed to enable surgeons to better suit patient anatomy. Newer developments include a recently initiated clinical trial comparing prodisc C Vivo and prodisc C SK devices with an approved TDR product as a control to validate safety and effectiveness in an FDA Investigational Device Exemption study.

Centinel Spine acquired the prodisc assets from DePuy Synthes in 2017.

Product Labels: Lumbar Spine, Spine Artificial Disc

Tags: Premarket Approval, Regulatory