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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBAK VISTA INTERBODY FUSION CAGE
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantZimmer Spine, Inc
7375 Bush Lake Road
Minneapolis, MN 55439
PMA NumberP950002
Supplement NumberS014
Date Received01/21/2004
Decision Date07/01/2004
Reclassified Date 07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO ADD THE FOLLOWING SIZES TO THE BAK VISTA DEVICE: 9X24 MM, 11X24 MM, 13X24 MM, 15X24 MM, 17X24 MM, 19X24 MM. THE BAK VISTA INTERBODY FUSION DEVICE, WHICH IS MANUFACTURED FROM 65% PEEK OPTIMA AND 35% TOHO BESFIGHT C6-UH CARBON FIBER, TO THE APPROVED PRODUCT LINE FOR THE BAK INTERBODY FUSION SYSTEM. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME BAK VISTA INTERBODY FUSION DEVICE AND IS INDICATED FOR USE WITH AUTOGENOUS BONE GRAFT IN PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT THE L2-S1 LEVELS. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVELS. BAK DEVICES ARE TO BE IMPLANTED VIA AN OPEN ANTERIOR OR POSTERIOR APPROACH. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. THESE PATIENTS WOULD BE SKELETALLY MATURE AND HAVE HAD SIX MONTHS OF NON-OPERATIVE TREATMENT.
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