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, Howmedica Corp. and Synthes (Usa).
130
Total
130
Cleared
131d
Avg days
1984
Since
130 devices
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 09, 1991
DEPUY (NITINO) GUIDE WIRE
Depuy, Inc.
Orthopedic
52d
Cleared
Nov 18, 1991
SONGER(TM) CABLE SYSTEM
Danek Medical, Inc.
Orthopedic
90d
Cleared
Jul 09, 1991
FX-CABLELOK SYSTEM
Biodynamic Technologies, Inc.
Orthopedic
50d
Cleared
Sep 10, 1990
STERNOTOMY CABLE, SONGER CABLE SYSTEM
Danek Medical, Inc.
Orthopedic
28d
Cleared
Jan 05, 1990
MENNEN BONE FIXATION DEVICE
Dentsply Intl.
Orthopedic
273d
Cleared
Sep 30, 1988
BONE FIXATION WIRE
Baxter Healthcare Corp
Orthopedic
77d
Cleared
Jan 20, 1988
STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM
Richards Medical Co., Inc.
Orthopedic
36d
Cleared
Jan 07, 1988
ORTHOMET WIRE FOR SUTURE, CERCLAGE
Orthomet, Inc.
Orthopedic
35d
Cleared
May 01, 1985
KIRSCHNER ORTHOPEDIC WIRE, EYELET CERCLAGE WIRES
Kirschner Medical Corp.
Orthopedic
71d
Cleared
Oct 26, 1984
ORTHOPAEDIC CABLE SYSTEM
Richards Medical Co., Inc.
Orthopedic
88d