Osteotech gets FDA clearance for Grafton DBM products

By Angela McDaniels

Seattle, Dec. 22 - Osteotech Inc. said the Food and Drug Administration has cleared its 510(k) Premarket Notification Application for the majority of its Grafton DBM products for use as bone graft extenders, bone graft substitutes and bone void fillers in orthopedic indications.

Covered in this application are Osteotech's Grafton DBM Gel, Putty, Flex, Matrix, Crunch and Orthoblend. Osteotech said the FDA previously cleared its 510(k) applications for Grafton Plus DBM Paste for use in dental and orthopedic procedures and its private-label Viagraf DBM Paste for orthopedic procedures.

"We are very pleased that in this most recent clearance, approval was received for Osteotech to process Grafton DBM products utilizing our current aseptic process or with our new validated, proprietary terminal sterilization process," president and chief operating officer Sam Owusu-Akyaw said in a company news release.

"We believe Grafton DBM is the only [demineralized bone matrix] product on the market to receive clearance for all of these indications and, we believe, the only DBM product to be cleared as a bone graft substitute.

"Our proprietary process is also 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. This validated process is used to further reduce the risk of disease transmission beyond the protection provided by donor testing and screening procedures."

Grafton DBM is an osteoinductive and osteoconductive, demineralized bone matrix product that is used for voids or gaps of the skeletal system not vital to the stability of the bony structure. Grafton DBM is remodeled and replaced by host bone during the healing process, the company said.

Medical device manufacturers are required to submit a Premarket Notification to the FDA if they plan to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified.

Osteotech is a biotechnology company based in Eatontown, N.J., that processes human bone and connective tissue for transplantation and develops biologic, biomaterial and device systems for musculoskeletal surgery.

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