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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namejoint, temporomandibular, implant
Generic Namejoint, temporomandibular, implant
Regulation Number872.3940
17301 west colfax avenue
suite 170
golden, CO 80401
PMA NumberP000023
Date Received06/20/2000
Decision Date01/05/2001
Product Code
LZD[ Registered Establishments with LZD ]
Docket Number 01M-0255
Notice Date 06/11/2001
Advisory Committee Dental
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the tmj fossa-eminence/condylar prosthesis system. The device is indicated for reconstruction of the temporomandibular joint. Patients should be considered if they have one or more of the following conditions: 1) inflammatory arthritis involving the temporomandibular joint not responsive to other modalities of treatment 2) recurrent fibrous and/or bony ankylosis not responsive to other modalities of treatment 3) failed tissue graft 4) failed alloplastic joint reconstruction 5) loss of vertical mandibular height and/or occlusal relationship due to bone resorption, trauma, developmental relationship due to bone resorption, trauma, developmental abnormality, or pathologic lesion.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S006 S007 S008 S009 S010