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 L device was first implanted in the U.S. during concurrent Investigational Device Exemption studies to obtain FDA approval for one- and two-level use. The first two-level implantation in the U.S. took place in 2002 as a part of the two-level study
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.
Fifteen companies have developed lumbar discs, including large entities such as Aesculap, DePuy Synthes, Globus Medical, NuVasive and Orthofix, and smaller or lesser-known companies such as Aditus, AxioMed, Simplify, TrueMotion and Viking Spine.