Centinel Spine has received the US Food and Drug Administration (FDA) approval for the manufacturing transfer of the prodisc C Cervical Total Disc Replacement and prodisc L Lumbar Total Disc Replacement systems to new strategic vendors.
The company obtained the approval following an extensive two-year process, involving FDA inspection audits at its prodisc manufacturing sites along with the approval of a PMA supplement by the agency.
According to the company, the approval will enable it to better manage its prodisc supply chain and associated costs.
Centinel Spine CEO Steve Murray said: “This approval is a major achievement by the company, thanks to a complete team effort by many involved.
“The team executed a well-designed plan that included three FDA facility audits, resulting in zero non-conformances or observations. The approval provides the company with control of prodisc manufacturing as we continue to advance both the prodisc cervical and prodisc lumbar systems.”
The company has a good presence in anterior column reconstruction since the acquisition of the prodisc Total Disc Replacement technology platform in 2017.
Centinel Spine is considered to be the only company with FDA-approved cervical and lumbar total disc replacement devices.
The company recently obtained FDA approval for two-level indications for the prodisc L Lumbar Total Disc Replacement system.
It has also initiated clinical trial comparing the prodisc C Vivo and prodisc C SK devices with an approved cervical TDR product as a control to validate their safety and effectiveness in an FDA IDE study.
The company started its operations in 2008 through the merger-acquisition of Raymedica and Surgicraft medical companies.