West Chester Medical Firm Gains Ground With FDA Decision

Centinel Spine

WEST CHESTER, PA — Centinel Spine has secured U.S. Food and Drug Administration approval to use its prodisc C Nova artificial cervical disc at two levels of the spine, expanding the West Chester medical device company’s approved treatment options for patients undergoing motion-preserving neck surgery.

The approval gives Centinel Spine three distinct cervical total disc replacement devices authorized for both one- and two-level procedures, strengthening its product portfolio in the U.S. spinal implant market.

The newly expanded authorization covers prodisc C Nova, which joins prodisc C Vivo and prodisc C SK. The latter two devices received FDA approval for two-level use in October 2025.

Total disc replacement involves replacing a damaged spinal disc with an artificial implant designed to preserve movement at the treated segment. The procedure offers a motion-preserving surgical option for appropriately selected patients.

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The expanded approval allows surgeons to use prodisc C Nova in procedures involving two cervical disc levels rather than limiting the device to single-level treatment.

Centinel Spine’s three cervical implants have different designs intended to accommodate variations in patient anatomy, giving surgeons additional choices when selecting devices for individual spinal levels.

“This optionality benefits my patients by allowing me to optimize implant fit and fixation based on anatomical variation,” said Christopher Summa, an orthopedic spine surgeon with Sutter Health in Santa Cruz, California.

Summa said the authorization expands the clinical applications of prodisc C Nova and provides another implant option for two-level procedures.

The device features flat endplates and low-profile keels designed to accommodate particular vertebral anatomy. It also incorporates the company’s prodisc CORE technology, which underlies the platform’s motion-preserving design.

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Prodisc C Nova has been used clinically outside the United States since 2009. It is currently available in the U.S. through a limited release.

The latest authorization builds on Centinel Spine’s strategy of offering multiple implant configurations rather than relying on a single cervical disc design.

The company markets this approach as Match-the-Disc, allowing surgeons to select implants according to anatomical differences and the requirements of each treated level.

“With three distinct prodisc cervical devices now approved for both one- and two-level use, we continue to expand our cervical portfolio,” said Steve Murray, Centinel Spine’s chief executive officer.

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Centinel Spine also offers lumbar total disc replacement devices. According to the company, prodisc remains the only total disc replacement platform in the United States with approvals for both one- and two-level procedures in the cervical and lumbar spine.

The FDA decision expands the authorized use of an existing product rather than introducing a new implant design.

For Centinel Spine, the approval broadens the clinical applications of its cervical portfolio and provides additional options for surgeons performing multilevel artificial disc replacement procedures.

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