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
Jan 15, 2016
Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
Zimmer, Inc.
Orthopedic
192d
Cleared
Jan 13, 2016
Frontier Medical Devices In-Line Orthopedic Cable Cerclage System
Frontier Medical Devices, Inc.
Orthopedic
65d
Cleared
Oct 30, 2015
Frontier Medical Devices In-line Orthopedic Cable Cerclage System
Frontier Medical Devices, Inc.
Orthopedic
112d
Cleared
Oct 29, 2015
DSM Biomedical DPR Cable
Dsm Biomedical
Orthopedic
304d
Cleared
Aug 20, 2015
Frontier Medical Devices Posterior Cable Screw System
Frontier Medical Devices, Inc.
Orthopedic
92d
Cleared
Jul 01, 2015
Suture Wires and Wire Loops
Zimmer, Inc.
Orthopedic
90d
Cleared
Jun 04, 2015
Tritium Sternal Cable Plate System
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Orthopedic
87d
Cleared
Jan 27, 2014
PERI-PROSTHETIC CABLE SYSTEM
Biomet, Inc.
Orthopedic
88d
Cleared
Jan 27, 2014
TRITIUM STERNAL CABLE PLATE SYSTEM
Pioneer Surgical Technology, Inc.
Orthopedic
46d
Cleared
Jul 25, 2013
COMPRESSYN BAND
Dallen Medical, Inc.
Orthopedic
154d
Cleared
Sep 13, 2012
JAZZ SYSTEM
Implanet, S.A.
Orthopedic
112d
Cleared
Jul 03, 2012
SPINAL ELEMENTS CERCLAGE SYSTEM
Spinal Elements, Inc.
Orthopedic
165d
Cleared
Feb 01, 2012
PASS LP SPINAL
Medicrea International
Orthopedic
134d
Cleared
Jul 28, 2011
SYNTHES STERNAL ZIPFIX SYSTEM
Synthes (Usa)
Orthopedic
128d
Cleared
Jul 06, 2011
FIGURE 8 STERNOTOMY CLOSURE DEVICE
Figure 8 Surgical, Incorporated
Orthopedic
131d
Cleared
May 20, 2011
K2M COCR WIRE
K2m, Inc.
Orthopedic
144d
Cleared
May 03, 2011
BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
Biomet Sports Medicine
Orthopedic
117d
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
Oct 23, 2007
BIOMET CABLE SYSTEM
Biomet Manufacturing, Inc.
Orthopedic
169d
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