PMA P070001S025

Device: prodisc C SK and prodisc C Vivo
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S025
Product code: MJO
Decision date: 2025-10-10
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
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.

Current openFDA PMA Record#

Device: prodisc C SK and prodisc C Vivo
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S025
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2025-10-10
Decision code: APPR
Date received: 2023-09-27
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.