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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction
Generic Nameinvertebral lumbar device
PMA NumberP000058
Supplement NumberS054
Date Received10/25/2013
Decision Date12/06/2013
Product Code
NEK[ Registered Establishments with NEK ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for extension of the rhbmp-2 drug substance expiration date from 60 to 72 months using the approved expiration date modification protocol. The device, as modified, will be marketed under the trade name infuse bone graft/lt-cage lumbar tapered fusion devices and is indicated for the following: 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 open anterior or a 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.