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. |
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Trade Name | OP-1 PUTTY FOR POSTEROLATERAL SPINAL FUSIONS |
Classification Name | filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde |
Generic Name | filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde |
Applicant |
OLYMPUS BIOTECH CORPORATION |
35 south st |
hopkinton, MA 01748 |
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HDE Number | H020008 |
Supplement Number | S020 |
Date Received | 12/14/2011 |
Decision Date | 12/27/2011 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
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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