JDW · Class II · 21 CFR 888.3040

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. and Stryker GmbH.

4
Total
4
Cleared
72d
Avg days
2021
Since

List of Pin, Fixation, Threaded devices cleared through 510(k)

4 devices
1–4 of 4
Cleared Dec 08, 2022
MAVERICK Mini External Fixation System
K223112
Smith & Nephew, Inc.
Orthopedic · 66d
Cleared Feb 11, 2022
MAVERICK External Fixation System
K213874
Smith & Nephew, Inc.
Orthopedic · 60d
Cleared Oct 05, 2021
Steinmann Pins and Kirschner Wires
K211508
Stryker GmbH
Orthopedic · 144d
Cleared Apr 02, 2021
Extended HA Half Pins
K210784
Smith & Nephew, Inc.
Orthopedic · 17d

How to use this database

This page lists all FDA 510(k) submissions for Pin, Fixation, Threaded devices (product code JDW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →