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
Jun 19, 2001
RESORBABLE HAMMERTOE PIN
Biomet, Inc.
Orthopedic
67d
Cleared
May 04, 2001
APEX FIXATION PINS
Howmedica Osteonics Corp.
Orthopedic
21d
Cleared
Nov 20, 2000
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
Synthes (Usa)
Orthopedic
90d
Cleared
Nov 03, 2000
BIOMET LATERAL TROCH PLATE
Biomet, Inc.
Orthopedic
14d
Cleared
Nov 02, 2000
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
Biomet, Inc.
Orthopedic
27d
Cleared
Aug 24, 2000
SYNTHES SACRAL BAR SYSTEM
Synthes (Usa)
Orthopedic
79d
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 18, 1998
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
Orthofix Srl
Orthopedic
131d
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
Mar 20, 1996
ORTHOFIX MODULSYSTEM
Orthofix, Inc.
Orthopedic
84d
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 30, 1990
RUSH PIN
Onyx Medical Corp.
Orthopedic
6d
Cleared
Jul 30, 1990
STEINMAN PIN, THREAD
Onyx Medical Corp.
Orthopedic
6d
Cleared
Jun 30, 1988
FIXATOR PIN (EXTERNAL)
Orthopedic Systems, Inc.
Orthopedic
80d
Cleared
Jan 14, 1988
ACE/FISCHER PERCUTANEOUS HALF PINS
Buckman Co., Inc.
Orthopedic
41d
Cleared
Jan 14, 1988
ACE PERCUTANEOUS 3MM HALF-PINS
Buckman Co., Inc.
Orthopedic
41d