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
73–94 of 94
Cleared Aug 18, 1995
POWERGRIP(TM) COMPRESSION FIXATION DEVICE
K950009
Synvasive Technology, Inc.
Orthopedic · 227d
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 Mar 07, 1995
KIRSCHNER (K-WIRE), STEINMAN PINS
K945670
Brasseler USA I, L.P.
Orthopedic · 109d
Cleared Mar 01, 1994
ORTHOPEDIC THREADED PIN FIXATION
K932349
Osteomed Corp.
Orthopedic · 291d
Cleared Jan 04, 1991
HAGIE PIN
K905347
O'Tec Corp.
Orthopedic · 37d
Cleared Dec 11, 1990
STEINMAN PIN, THREADED
K905336
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
KNOWLES PIN
K905344
O'Tec Corp.
Orthopedic · 13d
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 Sep 12, 1989
SKELETAL FIXATION PIN
K895173
Kronner Medical
Orthopedic · 33d
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
Cleared Jan 14, 1988
ACE/FISHER PERCUTANEOUS TRANSFIXING PINS
K875022
Buckman Co., Inc.
Orthopedic · 41d
Cleared Dec 30, 1987
ACE AND ACE/FISCHER PRE-DRILL PIN SYSTEM
K875021
Buckman Co., Inc.
Orthopedic · 26d
Cleared Jul 08, 1986
HOWMEDICA HOFFMANN FIXATION PIN SYSTEM
K861766
Howmedica Corp.
Orthopedic · 62d
Cleared Aug 02, 1984
PARTIALLY THREADED BONE FIX. PIN
K842293
Warsaw Orthopedic, Inc.
Orthopedic · 50d
Cleared Feb 09, 1984
CREIGHTON FIXATOR
K833907
Patton Machine Co.
Orthopedic · 87d
Cleared Feb 09, 1984
BROOKER EXTERNAL FIXATION FRAME
K840286
Depuy, Inc.
Orthopedic · 16d
Cleared Aug 31, 1978
THREADED PIN, SELF DRILLING
K781251
Ace Orthopedic Manufacturing Co.
Orthopedic · 41d
Cleared Aug 26, 1976
GOUFFON PIN, ADJUSTABLE
K760454
Howmedica Corp.
Orthopedic · 10d