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., Depuy, Inc. and Synthes (Usa).
94
Total
94
Cleared
78d
Avg days
1976
Since
94 devices
Cleared
Jan 14, 1988
ACE/FISHER PERCUTANEOUS TRANSFIXING PINS
Buckman Co., Inc.
Orthopedic
41d
Cleared
Dec 30, 1987
ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM
Buckman Co., Inc.
Orthopedic
26d
Cleared
Jul 08, 1986
HOWMEDICA HOFFMANN FIXATION PIN SYSTEM
Howmedica Corp.
Orthopedic
62d
Cleared
Feb 09, 1984
BROOKER EXTERNAL FIXATION FRAME
Depuy, Inc.
Orthopedic
16d
Cleared
Aug 26, 1976
GOUFFON PIN, ADJUSTABLE
Howmedica Corp.
Orthopedic
10d