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 Synthes (Usa), Howmedica Corp. and A & E Medical Corporation.
129
Total
129
Cleared
132d
Avg days
1984
Since
129 devices
Cleared
Jul 28, 2011
SYNTHES STERNAL ZIPFIX SYSTEM
Synthes (Usa)
Orthopedic
128d
Cleared
Jul 01, 2008
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
Synthes (Usa)
Orthopedic
63d
Cleared
Dec 27, 2006
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
Aesculap, Inc.
Orthopedic
86d
Cleared
Feb 25, 2005
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
Synthes (Usa)
Orthopedic
49d
Cleared
Jan 14, 2005
CABLING SYSTEM TROCHANTER HOOK
Smith & Nephew, Inc.
Orthopedic
52d
Cleared
Mar 02, 2004
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
Synthes (Usa)
Orthopedic
84d
Cleared
May 30, 2003
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
Synthes (Usa)
Orthopedic
16d
Cleared
May 01, 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
Smith & Nephew, Inc.
Orthopedic
17d
Cleared
Jun 27, 2001
SYNTHES STERNAL FIXATION SYSTEM
Synthes (Usa)
Orthopedic
90d
Cleared
Nov 02, 1999
SYNTHES CERCLAGE POSITIONING PIN
Synthes (Usa)
Orthopedic
67d
Cleared
Feb 24, 1999
DALL-MILES CABLE GRIP (A-GRIP)
Howmedica Osteonics Corp.
Orthopedic
72d
Cleared
Oct 19, 1998
BMP CABLE SYSTEM
Biomet, Inc.
Orthopedic
90d
Cleared
Jul 16, 1997
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE
Howmedica Corp.
Orthopedic
65d
Cleared
Aug 14, 1996
DALL-MILES TROCHANTER CABLE SUPERGRIP
Howmedica Corp.
Orthopedic
71d
Cleared
Jun 24, 1996
DALL-MILES STAINLESS STEEL BEADED CABLE
Howmedica Corp.
Orthopedic
62d
Cleared
May 22, 1996
DALL-MILES HOMOGENOUS VITALLIUM CABLE
Howmedica Corp.
Orthopedic
49d
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
Aug 01, 1994
DALL MILES SYSTEM GROOVED BUTTON
Howmedica Corp.
Orthopedic
347d
Cleared
Feb 25, 1994
CONTROL CABLE SYSTEM
Depuy, Inc.
Orthopedic
162d
Cleared
Feb 23, 1994
DALL MILES SYSTEM MINICLEAT
Howmedica Corp.
Orthopedic
188d
Cleared
Dec 09, 1991
DEPUY (NITINO) GUIDE WIRE
Depuy, Inc.
Orthopedic
52d
Cleared
Jan 05, 1990
MENNEN BONE FIXATION DEVICE
Dentsply Intl.
Orthopedic
273d