This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: INFUSE® Bone Graft
PMA Applicant: Medtronic Sofamor Danek
Address: 1800 Pyramid Place, Memphis, Tennessee 38132
Approval Date: March 9, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050053a.pdf
What is it? INFUSE® Bone Graft is a bone filling material for dental use, and contains a bone protein. It is an alternative to grafting a patient’s own bone.
How does it work? INFUSE® Bone Graft is used to fill space where bone is needed in order to place endosseous dental implants. Endosseous dental implants are inserted in the jaw and have an exposed head that can be used to secure dental devices like a crown, fixed bridge, or dentures.
When is it used? INFUSE® Bone Graft is used in making enough bone in the sinus area to place endosseous dental implants in the upper jaw. It is also used to increase bone in extraction sites prior to implant placement.
What will it accomplish? INFUSE® Bone Graft accomplishes almost the same clinical outcome as grafting a patient’s own bone into these locations but without the difficulties of grafting bone from the hip and other sites. Grafting sites usually have many side effects including pain and long recovery times.
When should it not be used? INFUSE® Bone Graft should not be used:
- In patients with an active infection at the operative site
- In patients who are pregnant
- In patients who are hypersensitive to recombinant human Bone Morphogenic Protein-2, or bovine type I collagen.
- In an area where there was a tumor.
Additional information: The Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050053