AUGMENT® Bone Graft
AUGMENT® Bone Graft is the only bioengineered and proven alternative to autograft in ankle and hindfoot fusions.
The product consists of two primary components: Medical grade β-TCP granules (1000-2000 μm) and rhPDGF-BB solution (0.3 mg/mL).
At the point of use, the two components are combined, mixed and subsequently applied to the surgical site. The β-TCP component of AUGMENT® Bone Graft provides a porous, osteoconductive scaffold to support cell attachment and delivery of rhPDGF-BB. AUGMENT® Bone Graft is designed for use in open hindfoot and ankle arthrodesis procedures.
Level 1 evidence of safety and effectiveness as a replacement to autograft in the largest F&A clinical trial ever conducted
Class III combination product specifically proven in, and labeled for, hindfoot and ankle arthrodesis via a rigorous PMA regulatory pathway
The only biologic product specifically engineered, proven, and approved for ankle and hindfoot fusions
Proven safe through multiple clinical trials and successful commercial use since 2009 in Canada and 2011 in Australia and New Zealand, while eliminating the proven risks, morbidities, and costs associated with autograft harvest
AUGMENT® Bone Graft is commercially available in Australia, New Zealand, Canada, and Mexico; and is now available in the U.S.
Brief Summary of Important Product Information
AUGMENT® Bone Graft Package Insert –