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Doctors Research Group wins 510(k) clearance for bone cement

November 18, 2009 by MassDevice staff

The Southbury, Conn.-based medical device maker wins clearance from the Food & Drug Administration for the use of Kryptonite bone cement in cranioplasty procedures.

Doctors Research Group wins 510(k) clearance for bone cement

Doctors Research Group Inc. won 510(k) clearance from the Food & Drug Administration for its Kryptonite bone cement in cranioplasty procedures.

The Southbury, Conn.-based medical device maker said the product is a non-toxic, low-exotherm cement and bone void filler. Traditional bone cements use polymethyl methacrylate (also known as Lucite), which doesn't bond to bone or implants. PMMA-based cements reach high temperatures while curing, which kills surrounding tissue, and also expose medical personnel to toxic fumes while being prepared.

DRG said Kryptonite eliminated these problems. It's a combination of three "naturally occurring" components that has adhesive properties, generates low temperatures while curing and is non-toxic, according to a press release. The company plans to bring the product to market immediately.

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