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.
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.
| Device | WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM |
| Generic Name | Joint, Temporomandibular, Implant |
| Applicant | BIOMET MICROFIXATION, INC. |
| Date Received | 2002-05-13 |
| Decision Date | 2005-09-21 |
| Notice Date | 2005-10-05 |
| PMA | P020016 |
| Supplement | S |
| Product Code | LZD |
| Docket Number | 05M-0399 |
| Advisory Committee | Dental |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOMET MICROFIXATION, INC. 1520 Tradeport Dr. jacksonville, FL 32218 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020016 | Original Filing | |
| S011 | 2019-11-18 | 30-day Notice |
| S010 | ||
| S009 | ||
| S008 | 2016-12-14 | Normal 180 Day Track No User Fee |
| S007 | 2014-11-10 | 30-day Notice |
| S006 | 2012-01-27 | 30-day Notice |
| S005 | 2010-05-18 | Normal 180 Day Track No User Fee |
| S004 | 2009-12-02 | Real-time Process |
| S003 | 2009-09-24 | Real-time Process |
| S002 | 2006-09-11 | Normal 180 Day Track No User Fee |
| S001 | 2006-04-28 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 00841036081898 | P020016 | 006 |
| 00841036060428 | P020016 | 006 |
| 00841036060398 | P020016 | 006 |
| 00841036060343 | P020016 | 006 |
| 00841036060329 | P020016 | 006 |
| 00841036036621 | P020016 | 006 |
| 00841036036607 | P020016 | 006 |
| 00841036036584 | P020016 | 006 |
| 00841036036560 | P020016 | 006 |
| 00841036036546 | P020016 | 006 |
| 00841036036522 | P020016 | 006 |
| 00841036036508 | P020016 | 006 |
| 00841036036454 | P020016 | 006 |
| 00841036036430 | P020016 | 006 |
| 00841036011895 | P020016 | 006 |
| 00841036011871 | P020016 | 006 |
| 00841036063580 | P020016 | 006 |
| 00841036064884 | P020016 | 006 |
| 00841036081881 | P020016 | 006 |
| 00841036081874 | P020016 | 006 |
| 00841036081867 | P020016 | 006 |
| 00841036081805 | P020016 | 006 |
| 00841036081799 | P020016 | 006 |
| 00841036081782 | P020016 | 006 |
| 00841036081744 | P020016 | 006 |
| 00841036081737 | P020016 | 006 |
| 00841036081720 | P020016 | 006 |
| 00841036081713 | P020016 | 006 |
| 00841036081560 | P020016 | 006 |
| 00841036081553 | P020016 | 006 |
| 00841036081386 | P020016 | 006 |
| 00841036081348 | P020016 | 006 |
| 00841036075118 | P020016 | 006 |
| 00841036011857 | P020016 | 006 |