Centinel Spine's Two-Level Approval Shows How PMA Supplements Work

Centinel Spine said on Oct. 14, 2026, that FDA has approved its prodisc C Nova artificial cervical disc for use at two spinal levels, in a company announcement. The West Chester, Pennsylvania, company said prodisc C Nova, prodisc C Vivo and prodisc C SK are now all approved for one- and two-level use. Chief executive Steve Murray said: "This approval represents another important advancement for our Match-the-Disc portfolio."

The approval did not come through a new application. FDA's premarket approval database records it as supplement S031 to the device's existing premarket approval, P070001. The supplement was received May 12, 2026, and approved Sept. 9, 2026, on what FDA calls the "Normal 180 Day Track." The approval order states the supplement requested "expansion of the indications from one-level use to two-level use."

Approval is not a one-time event

Premarket approval, or PMA, is FDA's review for Class III devices, those the agency says support or sustain human life or present a potential unreasonable risk of illness or injury. A cervical disc implant is regulated this way. Once a PMA is granted, the approval covers the device as described in the application. FDA's page on PMA supplements says the holder must submit a supplement and obtain approval "before making any change affecting the safety or effectiveness of the device."

FDA lists examples: new indications for use, labeling changes, a new manufacturing site, changes to manufacturing methods or quality controls, sterilization or packaging changes, and changes to design or performance specifications. Changes that do not affect safety or effectiveness can instead go in an annual report.

The supplement menu

The rules, in 21 CFR 814.39, set different tracks depending on how large the change is:

• Panel-track supplement: "for changes that request a significant change in design or performance of the device," reviewed much like an original PMA and potentially by an outside advisory panel.
• 180-day supplement: "for changes that affect the safety and effectiveness of the device," which FDA must approve before the change is made.
• Real-time supplement: for a minor change, such as a minor design change, reviewed in a meeting or similar exchange with FDA.
• Special PMA supplement, changes being effected: for a change that enhances the device's safety, which may take effect before FDA's written approval.
• 30-day notice: for changes to manufacturing procedures or methods; the change can proceed 30 days after FDA receives the notice unless the agency says otherwise. If FDA finds the notice inadequate, it becomes a 135-day supplement.

The prodisc C family's database history shows several of these in use. Its sister devices, the prodisc C SK and prodisc C Vivo, gained two-level indications in October 2025 through a panel-track supplement, S025. In January 2026, a 30-day notice, S030, approved using an existing endplate from a named supplier for the prodisc C Nova. An earlier 180-day supplement added a packaging location and a sterilization site.

What the record shows

For prodisc C Nova, the database lists the supplement reason as a labeling change to indications, with no expedited review and no predetermined change control plan. FDA notes on the record that a supplement may have changed the indication from the original approval, so the original PMA must be read alongside it.

Centinel said the device has been used outside the US since 2009 and is available in the US on a limited-release basis.