Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
Trade NameTMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES
Classification Namejoint, temporomandibular, implant
Regulation Number872.3940
ApplicantTMJ MEDICAL
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004 S006 S007 
S008 
-
-