‘Shocked’ Wright CEO Plans Appeal on Augment ‘Not Approvable’ Letter

Wright Medical said it will appeal the FDA’s decision not to approve the Augment bone graft as an alternative to autograft in hind foot and ankle fusion procedures. The “not approvable” letter cited agency concerns that the Augment clinical trial population was “predominantly low-risk and therefore may not have warranted the use of either autograft or Augment Bone Graft,” Wright said.
Devices & Diagnostics Letter