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
25–48 of 94
Cleared Jun 19, 2001
RESORBABLE HAMMERTOE PIN
K011137
Biomet, Inc.
Orthopedic · 67d
Cleared May 04, 2001
APEX FIXATION PINS
K011136
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Nov 20, 2000
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
K002605
Synthes (Usa)
Orthopedic · 90d
Cleared Nov 03, 2000
BIOMET LATERAL TROCH PLATE
K003294
Biomet, Inc.
Orthopedic · 14d
Cleared Nov 02, 2000
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
K003131
Biomet, Inc.
Orthopedic · 27d
Cleared Aug 24, 2000
SYNTHES SACRAL BAR SYSTEM
K001720
Synthes (Usa)
Orthopedic · 79d
Cleared Jul 12, 2000
APEX FIXATION PINS
K001886
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Feb 18, 2000
SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]
K994143
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Jul 14, 1999
DEPUY ROCKWOOD CLAVICLE PIN
K991649
Depuy, Inc.
Orthopedic · 62d
Cleared Aug 31, 1998
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
K982068
Howmedica Corp.
Orthopedic · 80d
Cleared Mar 18, 1998
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
K974186
Orthofix Srl
Orthopedic · 131d
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 Mar 20, 1996
ORTHOFIX MODULSYSTEM
K955848
Orthofix, Inc.
Orthopedic · 84d
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 Jul 30, 1990
RUSH PIN
K903261
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
STEINMAN PIN, THREAD
K903266
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jun 30, 1988
FIXATOR PIN (EXTERNAL)
K881511
Orthopedic Systems, Inc.
Orthopedic · 80d
Cleared Jan 14, 1988
ACE/FISCHER PERCUTANEOUS HALF PINS
K875012
Buckman Co., Inc.
Orthopedic · 41d
Cleared Jan 14, 1988
ACE PERCUTANEOUS 3MM HALF-PINS
K875013
Buckman Co., Inc.
Orthopedic · 41d