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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.
 
DeviceDUAL INTERFIX-RP(TM) THREADED FUSION DEVICE
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantSOFAMOR DANEK
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP970015
Supplement NumberS019
Date Received04/09/2001
Decision Date07/19/2001
Reclassified Date 07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR USE OF DUAL INTERFIX-RP(TM) THREADED FURSION DEVICES (INSTEAD OF THE ALREADY APPROVED USE OF A SINGLE INTERFIX-RP(TM) THREADED FUSION DEVICE USED IN CONJUNCTION WITH AN INTERFIX(TM) THREADED FUSION DEVICE) THE UNMODIFIED DEVICE WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME INTERFIX-RP(TM) THREADED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WTIH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS OR RETROLISTHESIS AT THE INVOLVED LEVEL. INTERFIX-RP(TM) THREADED FUSION DEVICES ARE TO BE USED WITH AUTOGENOUS BONE GRAFT AND IMPLANTED VIA AN OPEN ANTERIOR APPROACH. PATIENTS RECEIVING THE INTERFIX-RP(TM) THREADED FUSION DEVICES SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INTERFIX-RP(TM) THREADED FUSION DEVICE.
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