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..
130
Total
130
Cleared
131d
Avg days
1984
Since
130 devices
Cleared
Jan 27, 2014
PERI-PROSTHETIC CABLE SYSTEM
Biomet, Inc.
Orthopedic
88d
Cleared
Jul 03, 2012
SPINAL ELEMENTS CERCLAGE SYSTEM
Spinal Elements, Inc.
Orthopedic
165d
Cleared
Jul 28, 2011
SYNTHES STERNAL ZIPFIX SYSTEM
Synthes (Usa)
Orthopedic
128d
Cleared
May 20, 2011
K2M COCR WIRE
K2m, Inc.
Orthopedic
144d
Cleared
Jul 30, 2009
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
Zimmer Spine, Inc.
Orthopedic
98d
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
Oct 06, 2000
SPL CRIMP SYSTEM
Pioneer Surgical Technology
Orthopedic
86d
Cleared
Aug 31, 2000
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
Pioneer Surgical Technology
Orthopedic
87d
Cleared
Nov 23, 1999
PIONEER SILICOAT STERNAL CABLE
Pioneer Surgical Technology
Orthopedic
53d
Cleared
Nov 02, 1999
SYNTHES CERCLAGE POSITIONING PIN
Synthes (Usa)
Orthopedic
67d
Cleared
Oct 27, 1999
SDB CERCLAGE SYSTEM
Pioneer Surgical Technology
Orthopedic
84d
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
May 22, 1998
CABLE SCREW WITH INTEGRAL CRIMP
Pioneer Surgical Technology
Orthopedic
88d
Cleared
Dec 19, 1997
CERCLAGE CABLE WITH HEX BUTTON
Pioneer Surgical Technology
Orthopedic
58d
Cleared
Oct 27, 1997
COMPRESSION CERCLAGE GUNDOLF CCG-GF
Plus Orthopedics
Orthopedic
69d
Cleared
Jul 16, 1997
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE
Howmedica Corp.
Orthopedic
65d