FDA Product Code OWI: Bone Fixation Cerclage, Sublaminar

FDA product code OWI covers sublaminar bone fixation cerclage systems used in spinal surgery.

These cables or wires are passed beneath the laminae of the spine to serve as bone anchors for spinal instrumentation constructs, particularly in cases where pedicle screw fixation is not feasible due to anatomy, bone quality, or prior surgery.

OWI devices are Class II medical devices, regulated under 21 CFR 888.3010 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Medtronic, Inc., Medicrea International SA and Astura Medical.