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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 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS
Classification Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde
Generic Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde
Applicant
OLYMPUS BIOTECH CORPORATION
35 south st
hopkinton, MA 01748
HDE NumberH020008
Supplement NumberS022
Date Received04/02/2012
Decision Date04/23/2012
Product Code
OJZ
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 patient information brochure and summarized surgical technique. Op- i 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- 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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