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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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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 HDE to get an up-to-date view of this device.
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Generic Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
35 south st
hopkinton, MA 01748
HDE NumberH020008
Supplement NumberS019
Date Received08/03/2011
Decision Date10/12/2012
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for new cell banks for peoducing bulk op-1, as well as updates to the release and stability specs for op-1. Op-1 implant is indicated for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. Op-1 putty is indicated for the repair of symptomatic, posterolateral (intertransverse) lumbar spine pseudarthrosis in patients for whom autologous bone and/or bone marrow harvest are not feasible or are not expected to promote fusion and who have at least one of the following compromising factors; osteoporosis, diabetes or nicotine use.