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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 - hde
Generic Namefiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde
35 south st
hopkinton, MA 01748
HDE NumberH020008
Supplement NumberS012
Date Received08/17/2007
Decision Date04/17/2008
Product Code
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.