JDQ · Class II · 21 CFR 888.3010

FDA Product Code JDQ: Cerclage, Fixation

FDA product code JDQ covers cerclage fixation devices used to encircle and compress bone.

These cable, wire, or band systems are looped around bone to provide circumferential compression and stability in periprosthetic fractures, femoral fractures, and osteotomy fixation. They are used as adjuncts to intramedullary nails and plates when the bone cannot accept standard screw fixation.

JDQ devices are Class II medical devices, regulated under 21 CFR 888.3010 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Pioneer Surgical Technology, Synthes (Usa) and Howmedica Corp..

131
Total
131
Cleared
131d
Avg days
1984
Since
131 devices
97–120 of 131
Cleared Apr 19, 1994
SONGER CABLE SYSTEM
K941213
Pioneer Surgical Technology
Orthopedic · 41d
Cleared Mar 09, 1994
FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM
K935646
Biodynamic Technologies, Inc.
Orthopedic · 106d
Cleared Mar 09, 1994
FX-CABLELOK CABLE/PLATE SYSTEM
K935950
Buckman Co., Inc.
Orthopedic · 86d
Cleared Feb 25, 1994
CONTROL CABLE SYSTEM
K934557
Depuy, Inc.
Orthopedic · 162d
Cleared Feb 23, 1994
DALL MILES SYSTEM MINICLEAT
K934058
Howmedica Corp.
Orthopedic · 188d
Cleared Feb 22, 1994
CERCLAGE WIRE CRIMP SLEEVE
K931246
Acu Med, Inc.
Orthopedic · 348d
Cleared Feb 22, 1994
SURGICAL ACCESSORIES LOOPED WIRE
K934176
Surgical Accessories, Inc.
Orthopedic · 179d
Cleared Jan 26, 1994
SPONGER CABLE SYSTEM, MODIFICATION
K935481
Pioneer Surgical Technology
Orthopedic · 125d
Cleared Jan 26, 1994
SURGICAL ACCESSORIES COCR CABLE SYSTEM
K935592
Surgical Accessories, Inc.
Orthopedic · 68d
Cleared Nov 30, 1993
ORTHOPAEDIC POLYETHYLENE CABLE
K924141
Smith & Nephew Richards, Inc.
Orthopedic · 469d
Cleared Jun 29, 1993
OTI ORTHOPEDIC WIRE SYSTEM
K925447
Osteo Technology, Inc.
Orthopedic · 244d
Cleared May 19, 1993
STERNAL BAND
K930015
Stony Brook Surgical Innovations, Inc.
Orthopedic · 135d
Cleared May 12, 1993
CODMAN SOF'WIRE TITANIUM CABLE SYSTEM
K923869
Codman & Shurtleff, Inc.
Orthopedic · 282d
Cleared Mar 30, 1993
CODMAN SOFWIRE(TM) KIT
K926116
Codman & Shurtleff, Inc.
Orthopedic · 117d
Cleared Mar 24, 1993
TITANIUM SONGER CABLE SYSTEM
K925812
Sofamor Danek Mfg., Inc.
Orthopedic · 132d
Cleared Feb 23, 1993
SONGER CABLE SYSTEM
K922952
Pioneer Surgical Technology
Orthopedic · 250d
Cleared Nov 20, 1992
FX-CABLELOK SYSTEM
K922142
Bio-Tech Co.
Orthopedic · 198d
Cleared Jun 26, 1992
OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM
K921480
Acu Med, Inc.
Orthopedic · 88d
Cleared Apr 08, 1992
TITANIUM ALLOY SONGER CABLE SYSTEM
K920201
Sofamor Danek Mfg., Inc.
Orthopedic · 84d
Cleared Feb 07, 1992
FX-CABLELOK SYSTEM, MODIFICATION
K915259
Biodynamic Technologies, Inc.
Orthopedic · 80d
Cleared Jan 16, 1992
CODMAN SOF'WIRE (TM) KIT
K915581
Codman & Shurtleff, Inc.
Orthopedic · 34d
Cleared Dec 30, 1991
OSTEO CERCLAGE WIRE
K914374
Osteo AG
Orthopedic · 90d
Cleared Dec 09, 1991
DEPUY (NITINO) GUIDE WIRE
K914693
Depuy, Inc.
Orthopedic · 52d
Cleared Nov 18, 1991
SONGER(TM) CABLE SYSTEM
K913735
Danek Medical, Inc.
Orthopedic · 90d