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
May 22, 1996
DALL-MILES HOMOGENOUS VITALLIUM CABLE
Howmedica Corp.
Orthopedic
49d
Cleared
May 03, 1996
CERCLAGE WIRE CRIMP BLOCK
Acu Med, Inc.
Orthopedic
78d
Cleared
Mar 08, 1996
SYNTHES WIRE MOUNT
Synthes (Usa)
Orthopedic
207d
Cleared
Oct 12, 1995
DALL-MILES SUTURE/BEADED CABLE
Howmedica Corp.
Orthopedic
58d
Cleared
Mar 07, 1995
DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE
Howmedica Corp.
Orthopedic
127d
Cleared
Mar 06, 1995
CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK
Intermedics Orthopedics
Orthopedic
61d
Cleared
Feb 17, 1995
CABLE-EASE PLATE AND CABLE SYSTEM
Intermedics Orthopedics
Orthopedic
155d
Cleared
Feb 14, 1995
CCG CERCLAGE SYSTEM
Encore Orthopedics, Inc.
Orthopedic
659d
Cleared
Dec 21, 1994
PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES
Pioneer Surgical Technology
Orthopedic
306d
Cleared
Aug 01, 1994
DALL MILES SYSTEM GROOVED BUTTON
Howmedica Corp.
Orthopedic
347d
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
Jan 26, 1994
SPONGER CABLE SYSTEM, MODIFICATION
Pioneer Surgical Technology
Orthopedic
125d
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 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
Jun 26, 1992
OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM
Acu Med, Inc.
Orthopedic
88d