| 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. |
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| Device | TMJ FOSSA-EMINENCE PROSTHESIS(TM) |
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| Generic Name | Glenoid fossa prosthesis |
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| Regulation Number | 872.3950 |
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| Applicant | NEXUS CMF, LLC
17301 WEST COLFAX AVENUE
SUITE 170
GOLDEN, CO 80401 |
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| PMA Number | P000035 |
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| Date Received | 06/20/2000 |
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| Decision Date | 02/27/2001 |
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| Product Code |
MPI |
| Docket Number | 01M-0210 |
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| Notice Date | 05/14/2001 |
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| Advisory Committee |
Dental |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order 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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S010 S006 S007 S011 S001 S002 S003 S008 S009 S004 |
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