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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/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.
 
DeviceWALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
Generic NameJoint, temporomandibular, implant
Regulation Number872.3940
ApplicantBIOMET MICROFIXATION, INC.
1520 TRADEPORT DR.
JACKSONVILLE, FL 32218
PMA NumberP020016
Date Received05/13/2002
Decision Date09/21/2005
Product Code LZD 
Docket Number 05M-0399
Notice Date 10/05/2005
Advisory Committee Dental
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S011 
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