FDA Denies Wright Medical Group's Augment Bone Graft as Autograft Alternative

The U.S. Food and Drug Administration has denied Arlington, Tenn.-based Wright Medical Group's application to use the Augment Bone Graft for an alternative to autografts in foot and ankle fusions, according to a Daily News report. The agency's reasoning included the patient population for the trial, which the FDA said was low-risk and may not have truly needed an autograft or the Augment Bone Graft. In order to receive approval in the future, Wright Medical will need to prove patients in the trial are high-risk, according to the report.

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