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 Buckman Co., Inc..
94
Total
94
Cleared
78d
Avg days
1976
Since
94 devices
Cleared
Dec 04, 1998
SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01
Syntec Scientific Corp.
Orthopedic
42d
Cleared
Oct 21, 1998
THREADED FIXATION PIN
Sgarlato Laboratories, Inc.
Orthopedic
62d
Cleared
Aug 31, 1998
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
Howmedica Corp.
Orthopedic
80d
Cleared
Jul 17, 1998
EXTERNAL FIXATION
Avanta Orthopaedics, Inc.
Orthopedic
63d
Cleared
May 22, 1998
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
Alphatec Mfg., Inc.
Orthopedic
81d
Cleared
Mar 18, 1998
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
Orthofix Srl
Orthopedic
131d
Cleared
Mar 16, 1998
EXTERNAL FIXATOR
Avanta Orthopaedics, Inc.
Orthopedic
75d
Cleared
Apr 16, 1997
HEIDELBERG EXTERNAL FIXATOR
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic
44d
Cleared
Apr 03, 1997
COMPASS UNIVERSAL HINGE
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic
35d
Cleared
Mar 13, 1997
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
Synthes (Usa)
Orthopedic
59d
Cleared
Feb 28, 1997
HANSSON PIN SYSTEM
Osteonics Corp.
Orthopedic
84d
Cleared
Dec 16, 1996
DEPUY CANNULATED CROSS PIN SCREW SYSTEM
Depuy, Inc.
Orthopedic
74d
Cleared
Nov 06, 1996
THREADED FIXATION PIN
Orthopaedic Biosystems, Ltd.
Orthopedic
68d
Cleared
Sep 17, 1996
CROSS PIN
Medicinelodge, Inc.
Orthopedic
123d
Cleared
Mar 20, 1996
ORTHOFIX MODULSYSTEM
Orthofix, Inc.
Orthopedic
84d
Cleared
Mar 18, 1996
KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
Promex, Inc.
Orthopedic
76d
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
Mar 01, 1994
ORTHOPEDIC THREADED PIN FIXATION
Osteomed Corp.
Orthopedic
291d
Cleared
Jan 04, 1991
HAGIE PIN
O'Tec Corp.
Orthopedic
37d
Cleared
Dec 11, 1990
STEINMAN PIN, THREADED
O'Tec Corp.
Orthopedic
13d
Cleared
Dec 11, 1990
KNOWLES PIN
O'Tec Corp.
Orthopedic
13d