FDA Says Wright Medical Augment Bone Graft ‘Not Approvable’

 By Jim Dickinson

FDA has issued Wright Medical Group a “not approvable letter” in response to its PMA for Augment Bone Graft for use as an alternative to autograft in hindfoot and ankle fusion procedures.

In the letter, the agency says it is “concerned that the population enrolled was predominantly low risk and, therefore, may not have warranted the use of either autograft or Augment Bone Graft,” according to the company. It called for a new clinical study that evaluates the device as a “substitute for autograft in hindfoot and ankle fusion procedures in a well-defined high-risk target population, where the use of autograft would be clinically warranted.”

“In summary,” the company says, “the FDA concerns included ‘the patient population studied in the clinical study, the amount of graft material implanted, and the uncertainty as to whether any graft material would be needed or if the use of no graft material in a fusion procedure of the hindfoot and ankle in the population studied would have achieved similar results.’ FDA provided a number of additional observations about the clinical study design and results.”