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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.
 
DeviceBRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
Generic NameProsthesis, finger, constrained, metal/polymer
Regulation Number888.3220
ApplicantSTRYKER CORPORATION
BOHNACKERWEG 1
SELZACH CH 25
PMA NumberP960053
Date Received12/24/1996
Decision Date06/19/1997
Product Code KWG 
Docket Number 97M-0393
Notice Date 09/23/1997
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE AVANTA BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS. THIS DEVICE IS INDICATED FOR TOTAL JOINT REPLACEMENT IN SKELETALLY MATURE PATIENTS WITH PAIN OR INSTABILITY OF THE TRAPEZO-METACARPAL JOINT DUE TO TRAUMA, INFLAMMATORY OR DEGENERATIVE DISEASE OR REVISION OF PREVIOUS PROCEDURES, AS AN ALTERNATIVE TO ARTHRODESIS OR RECONSTRUCTIVE SURGERY.
Supplements:  S001 S002 S003 S004 S005 
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