Glenoid Fossa Prosthesis
Basic Information
- Device Name
- Glenoid Fossa Prosthesis
- Trade Name
- TMJ FOSSA-EMINENCE PROSTHESIS(TM)
- PMA Number
- P000035
- Device Class
- FDA Class 3
- Product Code
- MPI
- Generic Name
- Glenoid fossa prosthesis
- Regulation Number
- 872.3950
- Medical Specialty
- Dental
- Advisory Committee
- Dental
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 27, 2001
- Date Received
- June 20, 2000
- Expedited Review
- N
- Docket Number
- 01M-0210
Advisory Committee Statement
APPROVAL FOR THE TMJ FOSSA-EMINENCE PROSTHESIS(TM). THE DEVICE IS INDICATED FOR USE IN TREATMENT OF SEVERE TEMPOROMANDIBULAR JOINT DISEASE DUE TO: 1) INFLAMMATORY ARTHRITIS INVOLVING THE TEMPOROMANDIBULAR JOINT NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT, 2) RECURRENT FIBROSIS AND/OR BONY ANKYLOSIS NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT, 3) FAILED TISSUE GRAFT, 4) FAILED ALLOPLASTIC JOINT RECONSTRUCTION, 5) INTERNAL DERANGEMENT CONFIRMED TO BE PATHOLOGICAL IN ORIGIN BY BOTH CLINICAL OBSERVATION AND RADIOGRAPHIC FINDINGS, WHERE THE PATIENT HAS MODERATE TO SEVERE PAIN AND/OR DISABLING DYSFUNCTION AND HAS NOT RESPONDED TO LESS INVASIVE CONVENTIONAL THERAPY.
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 |
|---|---|---|---|
| MPI | Glenoid Fossa Prosthesis | FDA class 3 | Dental |