Frequently Asked Questions

1. How long has Grafton^® DBM been on the market?


Grafton^® DBM has been on the market for 15 years.



2. How can I purchase Grafton^® DBM?


Grafton^® DBM is available for sale directly from Osteotech, but may also be purchased from Musculoskeletal Transplant Foundation.



3. 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. Additionally, Osteotech conforms with all FDA and applicable state (NY, CA, MD, FL) regulations.



4. Is Grafton
^® DBM safe?


Grafton^® DBM has been the leading DBM for more than 15 years, as well as the most studied tissue on the market today. Grafton^® has been used clinically in over 650,000 procedures to date and a comprehensive , independent review of clinical data concluded that there is no evidence that Grafton^® DBM poses a safety risk to patients.



5. Is Grafton
^® DBM FDA approved?


Grafton^® DBM and Grafton Plus^® DBM have 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 package insert for complete 'Indications for Use'). We believe that this broad range of cleared indications for these products is unmatched by any other individual DBM product on the market to date.



6. 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.



7. What is the shelf life of Grafton^® DBM?


Grafton^® DBM Gel, Putty, Flex, Crunch and Matrix can be stored at 15°-30° C for a maximum of 3 years. Grafton^® DBM Orthoblend and Grafton Plus^® DBM Paste can be stored at 15°-30° C for a maximum of 2 years.



8. 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.