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
Jul 06, 2006
ALLOFIX ANCHOR, 5.0 MM ANCHOR
Musculoskeletal Transplant Foundation
Orthopedic
36d
Cleared
Jan 13, 2006
T-PIN
Union Surgical, LLC
Orthopedic
28d
Cleared
Sep 06, 2005
TAPERED COMPRESSION PIN
Nexa Orthopedics, Inc.
Orthopedic
70d
Cleared
Apr 12, 2004
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
Synthes (Usa)
Orthopedic
18d
Cleared
Jan 13, 2004
MODIFICATION TO JET-X HA COATED HALF PINS
Smith & Nephew, Inc.
Orthopedic
91d
Cleared
Feb 05, 2003
JET-X HA COATED HALF PINS
Smith & Nephew, Inc.
Orthopedic
72d
Cleared
Oct 09, 2002
JET-X TIN COATED HALF PINS
Smith & Nephew, Inc.
Orthopedic
19d
Cleared
May 13, 2002
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
Biomet, Inc.
Orthopedic
28d
Cleared
Mar 15, 2002
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
Stryker Endoscopy
Orthopedic
64d
Cleared
Sep 28, 2001
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
Stryker Endoscopy
Orthopedic
71d
Cleared
Sep 06, 2001
MODIFICATION TO THE TAC' PIN
New Deal, S.A.
Orthopedic
83d
Cleared
Jul 20, 2001
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
Stryker Endoscopy
Orthopedic
80d
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
Feb 01, 2000
TAC' PIN
New Deal, S.A.
Orthopedic
76d
Cleared
Nov 08, 1999
DIGIT WIDGET
Hand Biomechanics Lab, Inc.
Orthopedic
66d
Cleared
Jul 14, 1999
DEPUY ROCKWOOD CLAVICLE PIN
Depuy, Inc.
Orthopedic
62d
Cleared
Jun 01, 1999
STAINLESS STEEL FIXATION PINS
Bregma International Trading Company , Ltd.
Orthopedic
116d