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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameINFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
ApplicantMEDTRONIC SOFAMOR DANEK USA, INC.
PMA NumberP000058
Date Received12/22/2000
Decision Date07/02/2002
Product Code
NEK[ Registered Establishments with NEK ]
Docket Number 02M-0310
Notice Date 07/11/2002
Advisory Committee Orthopedic
Expedited Review Granted? Yes
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the infuse bone graft/lt-cage lumbar tapered fusion device. This 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. Infuse bone graft/lt-cage devices are to be implanted via an anterior open or an anterior laparoscopic approach. Patients receiving the infuse bone graft/lt-cage lumbar tapered fusion device should have had at least six months of nonoperative treatment prior to treatment with the infuse bone graft/lt-cage device.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S014 S015 
S016 S017 S019 S020 S021 S022 
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S030 S031 S032 S033 S034 S036 
S038 S039 S040 S041 S042 S043 
S044 S045 S046 S048 S050 S051 
S052 S053 
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