FDAnews Device Daily Bulletin

Panel Rejects Stryker OP-1 Bone Putty for PMA Approval

April 13, 2009
An FDA advisory committee voted 6–1 last week against recommending premarket approval (PMA) of Stryker Biotech’s OP-1 putty for use in an expanded patient population. The Orthopedic and Rehabilitation Devices Advisory Committee cited lingering concerns of whether the device promoted bone growth and pointed to safety issues regarding immunogenicity and maternal and fetal antibody transfer.
Devices & Diagnostics Letter