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
Jul 12, 2000
APEX FIXATION PINS
Howmedica Osteonics Corp.
Orthopedic
21d
Cleared
Feb 18, 2000
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]
Smith & Nephew, Inc.
Orthopedic
72d
Cleared
Jul 14, 1999
DEPUY ROCKWOOD CLAVICLE PIN
Depuy, Inc.
Orthopedic
62d
Cleared
Aug 31, 1998
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
Howmedica Corp.
Orthopedic
80d
Cleared
Mar 13, 1997
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
Synthes (Usa)
Orthopedic
59d
Cleared
Dec 16, 1996
DEPUY CANNULATED CROSS PIN SCREW SYSTEM
Depuy, Inc.
Orthopedic
74d
Cleared
Feb 09, 1996
RIGIDYNE A EXTERNAL FIXATION SYSTEM
Zimmer, Inc.
Orthopedic
50d
Cleared
Dec 13, 1995
DEPUY TITANIUM CROSS PIN FIXATION SYSTEM
Depuy, Inc.
Orthopedic
68d
Cleared
Jul 31, 1995
CANNULATED PLUS HIP SCREW
Wrightmedicaltechnologyinc
Orthopedic
52d
Cleared
May 15, 1995
CROSS PIN SCREW SYSTEM
Depuy, Inc.
Orthopedic
144d
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