Identity
- Trade Name
- PRODISC TM-C TOTAL DISC REPLACEMENT FDA PMA
- Generic Name
- Prosthesis, intervertebral disc FDA PMA
Identifiers
- PMA Number
- P070001 FDA PMA
- FDA Product Code
- MJO FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The ProDisc-C Total Disc Replacement is a Prosthesis, Intervertebral Disc (per FDA nomenclature) designed for single-level reconstruction of the cervical spine (C3–C7) following discectomy. It is intended for skeletally mature patients with symptomatic cervical disc disease, including radicular pain, neurological deficits, or functional impairment due to conditions such as herniated nucleus pulposus, spondylosis, or disc height loss confirmed by imaging.
Implanted via an open anterior approach, the device is supplied sterile and intended for single-use. Approved under FDA_PMA (P070001), it requires prior failure of non-operative treatment (minimum six weeks) before implantation. The system is classified as Class III and includes multiple FEI numbers for regulatory tracking. No MRI safety data or reusable variants are specified.
Frequently asked questions
What specific cervical spine levels can the ProDisc-C Total Disc Replacement be used for, and how is it implanted?
The ProDisc-C Total Disc Replacement is designed for single-level reconstruction of the cervical spine between vertebrae C3 and C7. It is implanted via an open anterior surgical approach following a discectomy, meaning the procedure involves an incision from the front of the neck to replace the damaged disc with the prosthesis.
Is the ProDisc-C Total Disc Replacement intended for patients with any specific conditions, and what prior treatment is required?
The device is intended for skeletally mature patients with symptomatic cervical disc disease, such as radicular pain, neurological deficits, or functional impairment due to conditions like herniated nucleus pulposus, spondylosis, or disc height loss confirmed by imaging. Patients must have failed at least six weeks of non-operative treatment before implantation, as per FDA requirements.
How is the ProDisc-C Total Disc Replacement supplied, and is it reusable?
The ProDisc-C Total Disc Replacement is supplied sterile and is intended for single-use only. There are no specifications indicating reusable variants, so each implant is designed for one-time surgical use.
What regulatory pathway was followed for the approval of the ProDisc-C Total Disc Replacement, and what classification does it hold?
The ProDisc-C Total Disc Replacement was approved under the FDA’s Premarket Approval (PMA) pathway, specifically under PMA number P070001. It is classified as a Class III medical device, which typically requires rigorous pre-market approval due to its substantial risk potential.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Centinel Spine | For prodisc® Motion-Preservation/Disc Arthroplasty ..., Centinel Spine | For prodisc® Motion-Preservation/Disc Arthroplasty ..., med+ from Centinel Spine | Centinel Spine Medical Education ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P070001 | Class III | Active |
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Manufacturer
- Manufacturer
- Centinel Spine, LLC
Sources (1)
- FDA PMA P070001 24 fields · synced Sep 18, 2026