| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
| |
| Device | WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM |
|---|
| Generic Name | Joint, temporomandibular, implant |
|---|
| Regulation Number | 872.3940 |
|---|
| Applicant | BIOMET MICROFIXATION, INC.
1520 TRADEPORT DR.
JACKSONVILLE, FL 32218 |
|---|
| PMA Number | P020016 |
|---|
| Date Received | 05/13/2002 |
|---|
| Decision Date | 09/21/2005 |
|---|
| Product Code |
LZD |
| Docket Number | 05M-0399 |
|---|
| Notice Date | 10/05/2005 |
|---|
| Advisory Committee |
Dental |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Recalls | CDRH Recalls |
|---|
Approval Order 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. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
|
|---|
| Post-Approval Study | Show Report Schedule and Study Progress |
|---|
| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S011 |
|
|
