Product code LZD
- Device name
- Joint, Temporomandibular, Implant
- Medical specialty
- Dental
- Device class
- 3
- Regulation number
- 872.3940
- Review panel
- DE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P980052S017 | TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis | Stryker Leibinger, GmbH & Co KG | 2026-03-06 |
| P020016S013 | Total Temporomandibular Joint Replacement System | Biomet Microfixation, Inc. | 2026-02-19 |
| P980052S016 | TMJ Concepts Patient Fitted Temporomandibular Joint (TMJ) Reconstruction Prosthesis System | Stryker Leibinger, GmbH & Co KG | 2025-07-23 |
| P980052S015 | TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis | Stryker Leibinger, GmbH & Co KG | 2024-08-08 |
| P980052S014 | TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis | Stryker Leibinger, GmbH & Co KG | 2024-07-30 |
| P980052S012 | TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st | Stryker Leibinger, GmbH & Co KG | 2023-08-22 |
| P980052S011 | TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis | Stryker Leibinger, GmbH & Co KG | 2022-08-31 |
| P980052S009 | Patient-Fitted TMJ Reconstruction Prosthesis System | Stryker Leibinger, GmbH & Co KG | 2021-04-27 |
| P980052S008 | Patient-Fitted TMJ Reconstruction Prosthesis System | Stryker Leibinger, GmbH & Co KG | 2020-11-24 |
| P980052S007 | Patient-Fitted TMJ Reconstruction Prosthesis System | Stryker Leibinger, GmbH & Co KG | 2020-01-10 |
| P020016S011 | Total Temporomandibular Joint Replacement System | Biomet Microfixation, Inc. | 2019-12-17 |
| P020016S008 | TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM | Biomet Microfixation, Inc. | 2017-06-08 |
| P000023S011 | TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM | Nexus CMF, LLC | 2015-02-13 |
| P020016S007 | TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM | Biomet Microfixation, Inc. | 2014-12-09 |
| P000023S009 | TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM | Nexus CMF, LLC | 2014-06-02 |
| P000023S010 | TMJ FOSSA-EMINENCE AND CONDY LAR PROSTHESIS SYSTEM | Nexus CMF, LLC | 2014-05-21 |
| P980052S005 | PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM | Stryker Leibinger, GmbH & Co KG | 2012-10-01 |
| P000023S008 | TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM | Nexus CMF, LLC | 2012-09-06 |
| P000023S007 | TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM | Nexus CMF, LLC | 2012-06-27 |
| P020016S006 | TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM | Biomet Microfixation, Inc. | 2012-03-15 |
| P000023S006 | TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM | Nexus CMF, LLC | 2012-01-31 |
| P020016S005 | TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM | Biomet Microfixation, Inc. | 2010-11-08 |
| P020016S004 | TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM | Biomet Microfixation, Inc. | 2010-01-29 |
| P020016S003 | TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM | Biomet Microfixation, Inc. | 2009-10-21 |
| P980052S004 | PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM | Stryker Leibinger, GmbH & Co KG | 2009-09-02 |
| P020016S002 | TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM | Biomet Microfixation, Inc. | 2006-10-13 |
| P020016S001 | TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM | Biomet Microfixation, Inc. | 2006-05-26 |
| P020016 | WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM | Biomet Microfixation, Inc. | 2005-09-21 |
| P000023S003 | TMJ FOSSA EMINENCE PROSTHESIS SYSTEM | Nexus CMF, LLC | 2004-01-22 |
| P000023S004 | TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM AND TMJ FOSSA-EMINENCE PROSTHESIS | Nexus CMF, LLC | 2003-10-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M9575000300 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 30) | Nexus Cmf, L.L.C. | 2014-11-10 |
| M9575000290 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 29) | Nexus Cmf, L.L.C. | 2014-11-10 |
| M9575000280 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 28) | Nexus Cmf, L.L.C. | 2014-11-10 |
| M9575000270 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 27) | Nexus Cmf, L.L.C. | 2014-11-10 |
| M9575000160 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 16) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000260 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 26) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000250 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 25) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000240 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 24) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000230 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 23) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000220 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 22) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000210 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 21) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000200 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 20) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000190 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 19) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000180 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 18) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000170 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 17) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000010 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 01) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000150 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 15) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000140 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 14) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000130 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 13) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000120 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 12) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000110 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 11) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000100 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 10) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000090 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 09) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000080 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 08) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000070 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 07) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000060 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 06) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000050 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 05) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000040 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 04) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000030 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 03) | Nexus Cmf, L.L.C. | 2014-11-06 |
| M9575000020 | Stock TMJ Fossa-Eminence Prosthesis (LEFT 02) | Nexus Cmf, L.L.C. | 2014-11-06 |