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
Cleared
Apr 19, 1994
SONGER CABLE SYSTEM
Pioneer Surgical Technology
Orthopedic
41d
Cleared
Mar 09, 1994
FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM
Biodynamic Technologies, Inc.
Orthopedic
106d
Cleared
Mar 09, 1994
FX-CABLELOK CABLE/PLATE SYSTEM
Buckman Co., Inc.
Orthopedic
86d
Cleared
Feb 25, 1994
CONTROL CABLE SYSTEM
Depuy, Inc.
Orthopedic
162d
Cleared
Feb 23, 1994
DALL MILES SYSTEM MINICLEAT
Howmedica Corp.
Orthopedic
188d
Cleared
Feb 22, 1994
CERCLAGE WIRE CRIMP SLEEVE
Acu Med, Inc.
Orthopedic
348d
Cleared
Feb 22, 1994
SURGICAL ACCESSORIES LOOPED WIRE
Surgical Accessories, Inc.
Orthopedic
179d
Cleared
Jan 26, 1994
SPONGER CABLE SYSTEM, MODIFICATION
Pioneer Surgical Technology
Orthopedic
125d
Cleared
Jan 26, 1994
SURGICAL ACCESSORIES COCR CABLE SYSTEM
Surgical Accessories, Inc.
Orthopedic
68d
Cleared
Nov 30, 1993
ORTHOPAEDIC POLYETHYLENE CABLE
Smith & Nephew Richards, Inc.
Orthopedic
469d
Cleared
Jun 29, 1993
OTI ORTHOPEDIC WIRE SYSTEM
Osteo Technology, Inc.
Orthopedic
244d
Cleared
May 19, 1993
STERNAL BAND
Stony Brook Surgical Innovations, Inc.
Orthopedic
135d
Cleared
May 12, 1993
CODMAN SOF'WIRE TITANIUM CABLE SYSTEM
Codman & Shurtleff, Inc.
Orthopedic
282d
Cleared
Mar 30, 1993
CODMAN SOFWIRE(TM) KIT
Codman & Shurtleff, Inc.
Orthopedic
117d
Cleared
Mar 24, 1993
TITANIUM SONGER CABLE SYSTEM
Sofamor Danek Mfg., Inc.
Orthopedic
132d
Cleared
Feb 23, 1993
SONGER CABLE SYSTEM
Pioneer Surgical Technology
Orthopedic
250d
Cleared
Nov 20, 1992
FX-CABLELOK SYSTEM
Bio-Tech Co.
Orthopedic
198d
Cleared
Jun 26, 1992
OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM
Acu Med, Inc.
Orthopedic
88d
Cleared
Apr 08, 1992
TITANIUM ALLOY SONGER CABLE SYSTEM
Sofamor Danek Mfg., Inc.
Orthopedic
84d
Cleared
Feb 07, 1992
FX-CABLELOK SYSTEM, MODIFICATION
Biodynamic Technologies, Inc.
Orthopedic
80d
Cleared
Jan 16, 1992
CODMAN SOF'WIRE (TM) KIT
Codman & Shurtleff, Inc.
Orthopedic
34d
Cleared
Dec 30, 1991
OSTEO CERCLAGE WIRE
Osteo AG
Orthopedic
90d
Cleared
Dec 09, 1991
DEPUY (NITINO) GUIDE WIRE
Depuy, Inc.
Orthopedic
52d
Cleared
Nov 18, 1991
SONGER(TM) CABLE SYSTEM
Danek Medical, Inc.
Orthopedic
90d