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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
1520 tradeport dr.
jacksonville, FL 32218
PMA NumberP020016
Date Received05/13/2002
Decision Date09/21/2005
Product Code
LZD[ Registered Establishments with 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 StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007