FDA WARNING_LETTER - Biostructures, LLC - May 17, 2010

On October 7, 2010, the FDA issued a Warning Letter to Biostructures, LLC, following an inspection from May 12-17, 2010. The inspection determined that Biostructures manufactures osteoMATRIX Synthetic Bone Graft Composite and osteoMATRIX Mineralized Collagen Scaffold devices.

The osteoMATRIX Synthetic Bone Graft Composite was found to be adulterated under section 501(f)(1)(B) of the Act because the firm lacked an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. It was also misbranded under section 502(o) of the Act, as notice for new intended uses was not provided to the FDA as required by section 510(k) and 21 CFR 807.81(a)(3)(ii).

The firm was promoting and marketing the osteoMATRIX Synthetic Bone Graft Composite for indications not cleared under K063527, including use mixed with bone marrow aspirate or autograft bone, in various fractures/revisions (hip, knee, high tibial plateau, foot/ankle), tibial and femoral osteotomies, as "grout" in shoulder arthroplasty, for "rapid bone remodeling," and to maintain osteoprogenitor cells at the graft site.

Biostructures, LLC was required to notify the FDA within fifteen working days of the specific steps taken to correct