Prosthesis, Intervertebral Disc
Basic Information
- Device Name
- Prosthesis, Intervertebral Disc
- Trade Name
- prodisc C SK and prodisc C Vivo
- PMA Number
- P070001
- Supplement Number
- S025
- Device Class
- FDA Class 3
- Product Code
- MJO
- Generic Name
- Prosthesis, intervertebral disc
- Medical Specialty
- Unknown
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 10, 2025
- Date Received
- September 27, 2023
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 25M-3465
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MJO | Prosthesis, Intervertebral Disc | FDA class 3 | Unknown |