Wright Medical Gains FDA Premarket Approval for AUGMENT Injectable Bone Graft

By Julie A. Vetalice

Wright Medical (WMGI) received FDA premarket approval for AUGMENT® Injectable Bone Graft, for the same clinical indications as AUGMENT® Bone Graft.  The combination product comprises recombinant human platelet derived growth factor (rhPDGF-BB) plus collagen and Beta tri-calcium phosphate, and serves as an alternative to autograft in hindfoot and ankle fusion.

U.S. launch will commence within the following two months. Following this approval, WMGI will update its 2018 revenue guidance in its 2Q18 earnings call.

Source: Wright Medical Group N.V.

Product Labels: Bone Graft Materials/DBM

Tags: 510(k) Clearance, Regulatory