Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: prodisc C SK and prodisc C Vivo
• Generic Name: Prosthesis, intervertebral disc
• Applicant: Centinel Spine, LLC; 900 Airport Rd., Suite 3b; West Chester, PA 19380
• PMA Number: P070001
• Supplement Number: S025
• Date Received: 09/27/2023
• Decision Date: 10/10/2025
• Product Code: MJO
• Docket Number: 25M-3465
• Notice Date: 10/24/2025
• Advisory Committee: Orthopedic
• Clinical Trials: NCT04012996
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls

Approval Order Statement  
The prodisc® C SK and prodisc® C Vivo are both indicated for use in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one or two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The prodisc® C SK and prodisc® C Vivo are implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite non-operative treatment prior to implantation of the prodisc® C SK and prodisc® C Vivo.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2