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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 NumberS027
Date Received11/16/2007
Decision Date03/21/2008
Product Code
NEK[ Registered Establishments with NEK ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the following modifications to the package insert: 1) inclusion of warnings related to localized, transient bone resorption and possible nerve compression due to ectopic bone formation prompted by a labeling modification required by the eu as a result of an analysis of reported adverse events; 2) inclusion of clinical and adverse event data resulting from the clinical post approval study; 3) inclusion of a warning related to adverse events potentially associated with over stuffing the scaffold component into a small volume or hyperconcentrating the recombinant human protein component; 4) inclusion of references to previously approved xs and xxs kits; and 5) strengthening the language stating that the components of the product may only be used together and not with other devices or components, e. G. , scaffolds other than the acs.