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Osteotech gets FDA approval for Grafton Plus DBM as bone graft extender
By E. Janene Geiss
Philadelphia, Nov. 29 - Osteotech, Inc. announced Tuesday that the Food and Drug Administration has cleared its 510(k) application to use Grafton Plus DBM Paste as a bone graft extender, bone graft substitute and bone void filler in orthopedic procedures.
The Grafton Plus for orthopedic use is the first of five 510(k) applications that the company has filed covering its family of Grafton DBM products, according to a company news release.
"To our knowledge, this is the only DBM product on the market to receive clearance as a bone graft extender, bone graft substitute and bone void filler," said Sam Owusu-Akyaw, president and chief operating officer, in the release.
Grafton Plus DBM Paste is a demineralized bone product that has been proven to be osteoinductive in an athymic rat in vivo model as well as being osteoconductive, officials said.
Results of bone formation studies in animals showed that Grafton Plus DBM Paste performed comparably to autograft, officials said. It is prepared utilizing a proprietary processing method that has been validated to consistently produce DBM that is osteoinductive in an athymic rat model and has been validated to inactivate a panel of viruses, including HIV-1, hepatitis B (using a duck hepatitis virus as a model), hepatitis C (using a bovine diarrhea virus as a model), CMV and polio, officials said.
Officials said they look forward to FDA approvals on the remaining four applications for the Grafton family of products.
Osteotech is an Eatontown, N.J., provider of human bone and bone connective tissue for transplantation and developer of biomaterial and implant products for musculoskeletal surgery.
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