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.