Prosthesis, Intervertebral Disc
Basic Information
- Device Name
- Prosthesis, Intervertebral Disc
- Trade Name
- Simplify Cervical Artificial Disc
- PMA Number
- P200022
- Supplement Number
- S003
- 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
- April 1, 2021
- Date Received
- October 27, 2020
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 21M-0355
Advisory Committee Statement
Approval for Simplify® Cervical Artificial Disc that is indicated for use in skeletally mature patients for reconstruction of the disc at one or two contiguous levels from C3-C7 following discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging (e.g., X-rays, computed tomography (CT), magnetic resonance imaging (MRI)): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. Patients receiving Simplify® Cervical Artificial Disc should have failed at least six weeks of non-operative treatment or demonstrated progressive signs or symptoms despite non-operative treatment prior to implantation. Simplify® Cervical Artificial Disc is implanted via an open anterior approach.
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 |