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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 south st
hopkinton, MA 01748
HDE NumberH010002
Supplement NumberS025
Date Received08/17/2007
Decision Date04/17/2008
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 the following manufacturing changes: i) elimination of ethanol as a processing solvent (47. 5% (v/v) etoh/0. 01 % tea (trifluoroacetic) replaced with 0. 01% (v/v) tfa); 2) change in op-i solution concentration from 0. 37-0. 4lmg/ml op-i to 0. 68-0. 72 op-1; 3) sequential powder (collagen matrix) and liquid (op- i solution) fill into each vial of op-1 implant 4) modified container closure system to address increased capacity/scalability, easier opening, and increased availability; 5) release specification change by altering in vitro biologic activity assay to improve accuracy and robustness; and 6) modified package insert to include changes to instructions for use to address modified container closure mechanism. The devices, as modified, will be marketed under the trade names op-i implant and op- i puttyand are indicated for recalcitrant tibia fractures and posterolateral fusion revision of failed posterolateral fusion surgeries of the lumbar spine, respectively.
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