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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.
 
DeviceINFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
Generic NameFiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
PMA NumberP000058
Supplement NumberS004
Date Received07/01/2003
Decision Date12/01/2003
Product Code NEK 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE INCLUSION OF ADDITIONAL FUSION CAGE COMPONENT DESIGNS FOR USE WITH THE INFUSE BONE GRAFT COMPONENT. THE FOLLOWING PART NUMBERS WERE NOT INCLUDED AS PART OF THIS REQUEST: 890226, 890229, 890243, 890246, 890249, 9012426 AND 9012429; THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAMES: INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE; INFUSE BONE GRAFT/INTER FIX THREADED FUSION DEVICE; AND INFUSE BONE GRAFT/INTER FIX RP THREADED FUSION DEVICE. FOR PURPOSES OF CLARITY, THE LT-CAGE LUMBAR TAPERED FUSION DEVICE, INTER FIX THREADED FUSION DEVCIE, AND INTER FIX RP THREADED FUSION DEVICE COMPONENTS ARE COLLECTIVELY REFERRED TO AS "INTERBODY FUSION DEVICE" FOR THE REMAINDER OF THIS APPROVAL ORDER. THE DEVICE IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L4-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY, FUNCTION DEFICIT AND/OR NEUROLOGICAL DEFICIT AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS MAY ALSO HAVE UP TO GRADE I SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. THE INFUSE BONE GRAFT/LT-CAGE DEVICES ARE TO BE IMPLANTED VIA AN ANTERIOR OPEN OR A LAPAROSCOPIC APPROACH. THE INFUSE BONE GRAFT/INTER FIX THREADED FUSION DEVICE; AND INFUSE BONE GRAFT/INTER FIX RP THREADED FUSION DEVICE ARE TO BE IMPLANTED VIA AN ANTERIOR OPEN APPROACH ONLY. PATIENTS RECEIVING THE INFUSE BONE GRAFT/INTERBODY FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INFUSE BONE GRAFT/INTERBODY FUSION DEVICE.
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