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.
FDA 510(k) Cleared Bone Fixation Cerclage, Sublaminar Devices (Product Code OWI)
About Product Code OWI - Regulatory Context
510(k) Submission Activity
36 total 510(k) submissions under product code OWI since 2011, with 36 receiving FDA clearance (average review time: 114 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
FDA review times for OWI submissions have been consistent, averaging 127 days recently vs 114 days historically.
OWI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →