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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(R) BONE GRAFT
Generic Namefiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 pyramid place
memphis, TN 38132
PMA NumberP000058
Supplement NumberS059
Date Received04/13/2015
Decision Date12/04/2015
Product Code NEK 
Advisory Committee Orthopedic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR EXPANSION OF THE APPROVED INDICATIONS FOR USE OF INFUSE BONE GRAFT TO INCLUDE IMPLANTATION WITH TWO ADDITIONAL INTERBODY FUSION DEVICES, THE PERIMETER INTERBODY FUSION DEVICE OR THE CLYDESDALE SPINAL SYSTEM, UTILIZING SELECT OPEN SURGICAL PROCEDURES IN CONJUNCTION WITH SUPPLEMENTAL SPINAL FIXATION HARDWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INFUSE BONE GRAFT/ MEDTRONIC INTERBODY FUSION DEVICE AND IS INDICATED FOR:SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH 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 GRADE 1 RETROLISTHESIS AT THE INVOLVED LEVEL. PATIENTS RECEIVING THE INFUSE BONE GRAFT/MEDTRONIC INTERBODY FUSION DEVICE SHOULD HAVE HAD AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO TREATMENT WITH THE INFUSE BONE GRAFT/MEDTRONIC INTERBODY FUSION DEVICE. THE FOLLOWING INTERBODY DEVICES AND SURGICAL APPROACHES MAY BE USED WITH INFUSE BONE GRAFT:1) THE LT-CAGE LUMBAR TAPERED FUSION DEVICE, IMPLANTED VIA AN ANTERIOR OPEN OR AN ANTERIOR LAPAROSCOPIC APPROACH AT A SINGLE LEVEL; 2) THE INTER FIX OR INTER FIX RP THREADED FUSION DEVICE, IMPLANTED VIA AN ANTERIOR OPEN APPROACH AT A SINGLE LEVEL; 3) THE PERIMETER INTERBODY FUSION DEVICE IMPLANTED VIA A RETROPERITONEAL ANTERIOR LUMBAR INTERBODY FUSION (ALIF) AT A SINGLE LEVEL FROM L2-S1OR AN OBLIQUE LATERAL INTERBODY FUSION (OLIF) APPROACH AT A SINGLE LEVEL FROM L5-S1; AND 4) THE CLYDESDALE SPINAL SYSTEM, IMPLANTED VIA AN OLIF APPROACH AT A SINGLE LEVEL FROM L2-L5.¿
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