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 Synthes (Usa).

94
Total
94
Cleared
78d
Avg days
1976
Since
94 devices
49–72 of 94
Cleared Jul 07, 2000
EXTERNAL FIXATION ANCHOR PIN
K001228
Immedica, Inc.
Orthopedic · 81d
Cleared Feb 18, 2000
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]
K994143
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Feb 01, 2000
TAC' PIN
K993910
New Deal, S.A.
Orthopedic · 76d
Cleared Nov 08, 1999
DIGIT WIDGET
K992970
Hand Biomechanics Lab, Inc.
Orthopedic · 66d
Cleared Jul 14, 1999
DEPUY ROCKWOOD CLAVICLE PIN
K991649
Depuy, Inc.
Orthopedic · 62d
Cleared Jun 01, 1999
STAINLESS STEEL FIXATION PINS
K990353
Bregma International Trading Company , Ltd.
Orthopedic · 116d
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