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 Biomet, Inc..

94
Total
94
Cleared
78d
Avg days
1976
Since
94 devices
25–48 of 94
Cleared Jul 26, 2006
PIN SCREW
K061599
Bk Meditech, Co., Ltd.
Orthopedic · 48d
Cleared Jul 07, 2006
APEX PINS
K061493
Stryker Howmedica Osteonics
Orthopedic · 37d
Cleared Jul 06, 2006
ALLOFIX ANCHOR, 5.0 MM ANCHOR
K061498
Musculoskeletal Transplant Foundation
Orthopedic · 36d
Cleared Jan 13, 2006
T-PIN
K053513
Union Surgical, LLC
Orthopedic · 28d
Cleared Sep 06, 2005
TAPERED COMPRESSION PIN
K051740
Nexa Orthopedics, Inc.
Orthopedic · 70d
Cleared Apr 12, 2004
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
K040765
Synthes (Usa)
Orthopedic · 18d
Cleared Jan 13, 2004
MODIFICATION TO JET-X HA COATED HALF PINS
K033289
Smith & Nephew, Inc.
Orthopedic · 91d
Cleared Oct 22, 2003
TARAS THREADED FIXATION PIN
K032532
Union Surgical, LLC
Orthopedic · 68d
Cleared Jun 24, 2003
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
K031154
Sintea Biotech, Inc.
Orthopedic · 74d
Cleared Mar 06, 2003
KMEDIC EXTERNAL FIXATION DEVICES
K030336
Teleflex Medical Group
Orthopedic · 34d
Cleared Feb 05, 2003
JET-X HA COATED HALF PINS
K023921
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Oct 09, 2002
JET-X TIN COATED HALF PINS
K023134
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared May 13, 2002
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
K021182
Biomet, Inc.
Orthopedic · 28d
Cleared Mar 15, 2002
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
K020097
Stryker Endoscopy
Orthopedic · 64d
Cleared Sep 28, 2001
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
K012270
Stryker Endoscopy
Orthopedic · 71d
Cleared Sep 06, 2001
MODIFICATION TO THE TAC' PIN
K011875
New Deal, S.A.
Orthopedic · 83d
Cleared Jul 20, 2001
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
K011319
Stryker Endoscopy
Orthopedic · 80d
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