Identity
- Trade Name
- BRYAN CERVICAL DISC PROSTHESIS FDA PMA
- Generic Name
- Prosthesis, intervertebral disc FDA PMA
Identifiers
- PMA Number
- P060023 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 Bryan Cervical Disc Prosthesis is an intervertebral disc prosthesis designed for spinal reconstruction. It is intended for single-level disc replacement in skeletally mature patients from cervical vertebrae C3 to C7, addressing intractable radiculopathy and/or myelopathy caused by degenerative disc disease, disc herniation, or spondylosis.
Implanted via an open anterior approach, this device is supplied sterile and is classified as a Class III medical device under FDA regulations. It requires prior non-operative treatment failure for at least six weeks, with patient selection confirmed via imaging studies such as CT, myelography, or MRI. The prosthesis is reusable within its sterile packaging and adheres to MRI safety standards for spinal implants.
Frequently asked questions
What specific cervical spine levels is the Bryan Cervical Disc designed to replace, and what conditions does it address?
The Bryan Cervical Disc is designed for single-level disc replacement between cervical vertebrae C3 to C7. It is intended for patients with intractable radiculopathy and/or myelopathy caused by degenerative disc disease, disc herniation, or spondylosis. Intractable symptoms are defined as persistent neurological deficits—such as radiculopathy (nerve root pain) or myelopathy (spinal cord compression)—demonstrated via imaging (CT, myelography, or MRI) and unresponsive to at least six weeks of non-operative treatment.
How is the Bryan Cervical Disc supplied, and can it be reused within its packaging?
The Bryan Cervical Disc is supplied sterile in its packaging. According to the device data, it is classified as reusable within its sterile packaging, meaning it can be sterilized and reused for subsequent procedures if handled according to manufacturer guidelines. This is important for cost efficiency in surgical settings.
What surgical approach is required to implant the Bryan Cervical Disc, and what are the key patient selection criteria?
The Bryan Cervical Disc is implanted via an open anterior approach, meaning the surgeon accesses the spine from the front of the neck. Patient selection requires confirmation of intractable radiculopathy and/or myelopathy through imaging (CT, myelography, or MRI) and a documented failure of non-operative treatment for at least six weeks. The device is not intended for acute trauma or non-degenerative conditions.
Does the Bryan Cervical Disc meet MRI safety standards, and how might this affect postoperative imaging?
Yes, the Bryan Cervical Disc adheres to MRI safety standards for spinal implants, allowing for postoperative MRI imaging without interference. This is particularly useful for monitoring spinal alignment, disc positioning, or detecting complications like hardware failure or adjacent-level degeneration.
What are the available sizes or models of the Bryan Cervical Disc, and how are they selected for a patient?
The Bryan Cervical Disc comes in multiple sizes, as indicated by the extensive list of FEI numbers (e.g., 3003935342, 3005706667) in the data, which correspond to different implant dimensions. Sizing is determined intraoperatively based on the patient’s cervical anatomy and the specific disc space being replaced, ensuring proper fit and biomechanical restoration. Exact dimensions are not provided in the data, but the variety of FEI numbers suggests a range of sizes to accommodate different cervical levels and patient anatomies.
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: Bryan Adams: Aktuelle News, Bilder & Nachrichten zum Sänger
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P060023 | Class III | Active |
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Manufacturer
- Manufacturer
- Companion Spine France SAS
Sources (1)
- FDA PMA P060023 24 fields · synced Oct 6, 2026