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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.
 
Trade NameOP-1 IMPLANT
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Generic Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction
Applicant
Olympus Biotech Corporation
35 s. st.
hopkinton, MA 01748
HDE NumberH010002
Supplement NumberS031
Date Received12/14/2011
Decision Date12/27/2011
Product Code
MPW[ Registered Establishments with MPW ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement 
Approval for modifications to the package insert and an update to the risk analysis to include additional risks associated with antibody cross-reactivity. Op-1implant 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-i putty is indicated for the repair of symptomatic, posterolateral (intertransverse) lumbar spine pseudoarthrosis 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.
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