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CERVICAL TOTAL DISC REPLACEMENT

prodisc C Vivo & prodisc C SK are now FDA-approved for 2-level use!

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A landmark IDE Clinical Study featuring prodisc C Vivo & prodisc C SK demonstrated the safety and clinical effectiveness of matching the disc to each individual spinal level.1

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Centinel Spine Receives Two-Level FDA Approval for prodisc C Vivo & prodisc C SK Match-the-Disc™ Cervical Total Disc Replacement (TDR) Devices

The prodisc C Vivo & prodisc C SK are now indicated for reconstruction of a vertebral disc from C3-C7 following discectomy at one level or two contiguous levels.
The prodisc C Vivo & prodisc C SK Match-the-Disc™ System is the first and only cervical TDR system with two different devices approved for both one- and two-level use.
Centinel Spine’s prodisc technology is now the only TDR solution in the U.S. approved for one- and two-level use in both the cervical and lumbar spine.

prodisc C Vivo & prodisc C SK

FAST FACTS

  • October 2025: U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for 2-level indications
  • July 2022: U.S. FDA PMA for 1-level indications
  • Since receiving FDA approval for 1-level indications, nearly 20,000 prodisc C Vivo & prodisc C SK spinal levels have been implanted in the U.S. by over 1,100 surgeons (through September 2025)
  • The prodisc C Vivo device has been in clinical use internationally since 2009 and is currently one of the most frequently implanted TDR devices in the world
  • Together, prodisc C Vivo & prodisc C SK (along with prodisc C* & prodisc C Nova*) form the Match-the-Disc™ Cervical TDR System, which allows surgeons to intraoperatively select the implant design that’s best for the patient
* prodisc C & prodisc C Nova are approved for 1-level usage only.

Landmark IDE Clinical Study Supporting the PMA

FAST FACTS

  • A total of 480 subjects were enrolled across 31 centers, and the PMA is based on the analysis of 433 subjects—which is the highest number of subjects used to support a PMA for any cervical TDR device on the market.
  • The study is the first of its kind to evaluate two investigational TDR devices and the first PMA based on an IDE study that compares an investigational system to a PMA approved cervical TDR device.
  • Patients treated with prodisc C Vivo & prodisc C SK had statistically non-inferior (i.e. equivalent) outcomes versus patients treated with the control cervical TDR device.1
  • The prodisc C Vivo & prodisc C SK Cervical TDR system achieved the highest overall composite clinical success rate at two-levels compared to any approved cervical total disc replacement device.
1 Refer to the Summary of Safety and Effectiveness Data at 2level.centinelspine.com.
  prodisc C Vivo / SK Mobi-C®
Implanted 291 140
No secondary surgical intervention 96.9% 95.7%
No Neurological Deterioration*** (CEC) 98.0% 96.8%
No Major Adverse Event (CEC) 99.7% 100%
NDI 15-point Responder*** 93.9% 90.1%
Composite Clinical Success Results** 87.1%* 83.7%
Data is based on mITT Analysis Set. * The success rate without imputation (i.e. for patients reaching 24-month endpoint) for prodisc C Vivo / prodisc C SK is 87.1% and the success rate for prospective Mobi-C is 83.7%. This success rate uses posterior probability to demonstrate that non-inferiority has been achieved. ** Composite Clinical Success requires successfully meeting all four primary endpoints. *** Censored for SSI at the Index Level.
FDA Approved Two-Level Cervical Disc 24 Month PMA Study Composite Clinical Success Rate
prodisc C Vivo & prodisc C SK 87.1% i
Simplify 86.7% ii
Prestige LP 81.4% iii
Mobi-C 69.7% iv
The Study Success Rate reported is based on the Overall Success rate of the Primary Analysis Population in the SSED for each cervical total disc replacement device with two level indications:
i prodisc C Vivo / prodisc C SK SSED, (P070001 / S025). ii Simplify SSED (P200022 / S003). iii Prestige LP SSED (P090029 / S003). iv Mobi-C SSED (P110009).
View the Announcement (Press Release)

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prodisc C Vivo
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The Story of Centinel Spine

Watch this short primer on Centinel Spine and its unique and extraordinary place as a catalyst of change in the spine industry—with pioneering technologies and a clinical history that have led to successes ranging from PGA champions to a growing list of surgeon-patients.

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Centinel Spine®

900 Airport Road, Suite 3B
West Chester, PA 19380

Tel: 484.887.8810
Fax: 800.493.0966

Email:  info@centinelspine.com

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