Prosthesis, Intervertebral Disc
Basic Information
- Device Name
- Prosthesis, Intervertebral Disc
- Trade Name
- PRODISC TM-C TOTAL DISC REPLACEMENT
- PMA Number
- P070001
- 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
- December 17, 2007
- Date Received
- January 3, 2007
- Expedited Review
- N
- Docket Number
- 08M-0013
Advisory Committee Statement
APPROVAL FOR THE PRODISC-C TOTAL DISC REPLACEMENT. THE DEVICE IS INDICATED FOR SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE SYMPTOMATIC CERVICAL DISC DISEASE (SCDD). SYMPTOMATIC CERVICAL DISC DISEASE IS DEFINED AS NECK OR ARM (RADICULAR) PAIN AND/OR A FUNCTIONAL/NEUROLOGICAL DEFICIT WITH AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY IMAGING (CT, MRI, OR X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR LOSS OF DISC HEIGHT. THE PRODISC-C TOTAL DISC REPLACEMENT IS IMPLANTED VIA AN OPEN ANTERIOR APPROACH. PATIENTS RECEIVING THE PRODISC-C TOTAL DISC REPLACEMENT SHOULD HAVE FAILED AT LEAST SIX WEEKS OF NON-OPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE PRODISC-C TOTAL DISC REPLACEMENT.
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 |