Frequently Asked Questions
How long has Grafton DBM been available?
Grafton DBM has been on the market since 1991.
How can I purchase Grafton DBM? Grafton DBM is available for sale directly from Osteotech. Customer Service is available to assist you Monday through Friday from 8 a.m. to 8 p.m. EST. You can reach the Customer Service department at 800-469-4005.
Is Osteotech accredited by the American Association of Tissue Banks (AATB)?
Yes, Osteotech tissue is made available under AATB accredited recovery, processing, and distribution standards. In addition, Osteotech conforms with all FDA and applicable state (NY, CA, MD, FL) regulations.
Is Grafton DBM safe?
Grafton DBM has been the leading DBM for more than 17 years, as well as the most studied tissue on the market today. To date, Grafton DBM has been used clinically in over 800,000 procedures. A comprehensive, independent review of clinical data concluded that there is no evidence that Grafton DBM poses a safety risk to patients.
Is Grafton DBM FDA approved?
Grafton DBM and Grafton Plus® DBM have each been 510(k) cleared by the FDA as a bone void filler, bone graft extender, and bone graft substitute for use in a variety of skeletal sites (see individual package inserts for complete "Indications for Use"). We believe this broad range of cleared indications for these products is unmatched by any other individual DBM product on the market to date1.
How do I know my allograft does not contain any viruses?
Osteotech has a validated process for viral inactivation. There has never been a confirmed incident of communicable disease transmission attributed to Grafton DBM.
What is the shelf life of Grafton DBM?
Grafton DBM Gel, Grafton DBM Putty, Grafton DBM Flex, Grafton DBM A-Flex®, Grafton DBM Crunch, and Grafton DBM Matrix can be stored at 15°-30° C for a maximum of 3 years from the date of manufacture. Grafton DBM Orthoblend and Grafton Plus DBM Paste can be stored at 15°-30° C for a maximum of 2 years from date of manufacture. Refer to product label for actual expiration date.
Is there any preparation necessary prior to using Grafton DBM?
No. Grafton DBM comes ready-to-use out of the package. There is no preparation necessary.
*Refer to package insert for detailed product information.