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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 Namefinger semi-constrained pyrolytic carbon uncemented prosthesis
Generic Namefinger semi-constrained pyrolytic carbon uncemented prosthesis
8900 cameron road
austin, TX 78754
PMA NumberP000057
Date Received12/29/2000
Decision Date11/19/2001
Product Code
NEG[ Registered Establishments with NEG ]
Docket Number 01M-0530
Notice Date 11/29/2001
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
This device is indicated for use as a total joint replacement of index, long, ring, and small finger metacarpophalangeal joints that exhibit symptoms of pain, limited motion, or inadequate bony alignment (i. E. , subluxation/dislocation) secondry to articular destruction or degenerative disease related to rheumatoid arthritis, lupus erythematosus, osteoarthritis, or post traumatic arthritis where soft tissue reconstruction can provide adequate stabilization.
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 S005 S006 S007