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., Depuy, Inc. and Buckman Co., Inc..

94
Total
94
Cleared
78d
Avg days
1976
Since
94 devices
49–72 of 94
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
K983757
Syntec Scientific Corp.
Orthopedic · 42d
Cleared Oct 21, 1998
THREADED FIXATION PIN
K982931
Sgarlato Laboratories, Inc.
Orthopedic · 62d
Cleared Aug 31, 1998
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
K982068
Howmedica Corp.
Orthopedic · 80d
Cleared Jul 17, 1998
EXTERNAL FIXATION
K981716
Avanta Orthopaedics, Inc.
Orthopedic · 63d
Cleared May 22, 1998
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
K980788
Alphatec Mfg., Inc.
Orthopedic · 81d
Cleared Mar 18, 1998
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
K974186
Orthofix Srl
Orthopedic · 131d
Cleared Mar 16, 1998
EXTERNAL FIXATOR
K974911
Avanta Orthopaedics, Inc.
Orthopedic · 75d
Cleared Apr 16, 1997
HEIDELBERG EXTERNAL FIXATOR
K970751
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 44d
Cleared Apr 03, 1997
COMPASS UNIVERSAL HINGE
K970713
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 35d
Cleared Mar 13, 1997
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
K970097
Synthes (Usa)
Orthopedic · 59d
Cleared Feb 28, 1997
HANSSON PIN SYSTEM
K964893
Osteonics Corp.
Orthopedic · 84d
Cleared Dec 16, 1996
DEPUY CANNULATED CROSS PIN SCREW SYSTEM
K963973
Depuy, Inc.
Orthopedic · 74d
Cleared Nov 06, 1996
THREADED FIXATION PIN
K963433
Orthopaedic Biosystems, Ltd.
Orthopedic · 68d
Cleared Sep 17, 1996
CROSS PIN
K961920
Medicinelodge, Inc.
Orthopedic · 123d
Cleared Mar 20, 1996
ORTHOFIX MODULSYSTEM
K955848
Orthofix, Inc.
Orthopedic · 84d
Cleared Mar 18, 1996
KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
K960023
Promex, Inc.
Orthopedic · 76d
Cleared Feb 09, 1996
RIGIDYNE A EXTERNAL FIXATION SYSTEM
K955780
Zimmer, Inc.
Orthopedic · 50d
Cleared Dec 13, 1995
DEPUY TITANIUM CROSS PIN FIXATION SYSTEM
K954630
Depuy, Inc.
Orthopedic · 68d
Cleared Jul 31, 1995
CANNULATED PLUS HIP SCREW
K952640
Wrightmedicaltechnologyinc
Orthopedic · 52d
Cleared May 15, 1995
CROSS PIN SCREW SYSTEM
K946228
Depuy, Inc.
Orthopedic · 144d
Cleared Mar 01, 1994
ORTHOPEDIC THREADED PIN FIXATION
K932349
Osteomed Corp.
Orthopedic · 291d
Cleared Jan 04, 1991
HAGIE PIN
K905347
O'Tec Corp.
Orthopedic · 37d
Cleared Dec 11, 1990
STEINMAN PIN, THREADED
K905336
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
KNOWLES PIN
K905344
O'Tec Corp.
Orthopedic · 13d