Joint, Temporomandibular, Implant
Basic Information
- Device Name
- Joint, Temporomandibular, Implant
- Trade Name
- WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
- PMA Number
- P020016
- Device Class
- FDA Class 3
- Product Code
- LZD
- Generic Name
- Joint, temporomandibular, implant
- Regulation Number
- 872.3940
- Medical Specialty
- Dental
- Advisory Committee
- Dental
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 21, 2005
- Date Received
- May 13, 2002
- Expedited Review
- N
- Docket Number
- 05M-0399
Advisory Committee Statement
APPROVAL FOR THE TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM. THE DEVICE IS INDICATED FOR RECONSTRUCTION OF THE TEMPOROMANDIBULAR JOINT. THE RECONSTRUCTION IS NECESSARY DUE TO ONE OF THE FOLLOWING DIAGNOSES: 1) ARTHRITIC CONDITIONS: OSTEOARTHRITIS, TRAUMATIC ARTHRITIS, RHEUMATOID ARTHRITIS, 2) ANKYLOSIS INCLUDING BUT NOT LIMITED TO RECURRENT ANKYLOSIS WITH EXCESSIVE HETEROTOPIC BONE FORMATION, 3) REVISION PROCEDURES WHERE OTHER TREATMENTS HAVE FAILED (E.G. ALLOPLASTIC RECONSTRUCTION, AUTOGENOUS GRAFTS), 4) AVASCULAR NECROSIS, 5) MULTIPLY OPERATED JOINTS, 6) FRACTURE, 7) FUNCTIONAL DEFORMITY, 8) BENIGN NEOPLASMS, 9) MALIGNANCY (E.G. POST-TUMOR EXCISION), 10) DEGENERATED OR RESORBED JOINTS WITH SEVERE ANATOMIC DISCREPANCIES, AND 11) DEVELOPMENTAL ABNORMALITY.
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 |
|---|---|---|---|
| LZD | Joint, Temporomandibular, Implant | FDA class 3 | Dental |