FDA Product Code JDW: Pin, Fixation, Threaded
Under FDA product code JDW, threaded fixation pins are cleared for bone stabilization in orthopedic and trauma surgery.
Unlike smooth Kirschner wires, threaded pins have a helical thread that engages bone and resists pullout, providing more stable fixation for small bone fragments, external fixator frames, and temporary stabilization of fractures pending definitive repair.
JDW devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Smith & Nephew, Inc., Biodynamik, Inc. and Stryker GmbH.
FDA 510(k) Cleared Pin, Fixation, Threaded Devices (Product Code JDW)
About Product Code JDW - Regulatory Context
510(k) Submission Activity
94 total 510(k) submissions under product code JDW since 1976, with 94 receiving FDA clearance (average review time: 78 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under JDW have taken an average of 184 days to reach a decision - up from 75 days historically. Manufacturers should account for longer review timelines in current project planning.
JDW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →