JDQ · Class II · 21 CFR 888.3010

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).

131
Total
131
Cleared
131d
Avg days
1984
Since
131 devices
25–48 of 131
Cleared Apr 06, 2016
KLS Martin LSS Plating System
K151983
KLS-Martin L.P.
Orthopedic · 264d
Cleared Jan 15, 2016
Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
K151848
Zimmer, Inc.
Orthopedic · 192d
Cleared Jan 13, 2016
Frontier Medical Devices In-Line Orthopedic Cable Cerclage System
K153242
Frontier Medical Devices, Inc.
Orthopedic · 65d
Cleared Oct 30, 2015
Frontier Medical Devices In-line Orthopedic Cable Cerclage System
K151888
Frontier Medical Devices, Inc.
Orthopedic · 112d
Cleared Oct 29, 2015
DSM Biomedical DPR Cable
K143716
Dsm Biomedical
Orthopedic · 304d
Cleared Aug 20, 2015
Frontier Medical Devices Posterior Cable Screw System
K151346
Frontier Medical Devices, Inc.
Orthopedic · 92d
Cleared Jul 01, 2015
Suture Wires and Wire Loops
K150889
Zimmer, Inc.
Orthopedic · 90d
Cleared Jun 04, 2015
Tritium Sternal Cable Plate System
K150581
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Orthopedic · 87d
Cleared Jan 27, 2014
PERI-PROSTHETIC CABLE SYSTEM
K133354
Biomet, Inc.
Orthopedic · 88d
Cleared Jan 27, 2014
TRITIUM STERNAL CABLE PLATE SYSTEM
K133785
Pioneer Surgical Technology, Inc.
Orthopedic · 46d
Cleared Jul 25, 2013
COMPRESSYN BAND
K130431
Dallen Medical, Inc.
Orthopedic · 154d
Cleared Sep 13, 2012
JAZZ SYSTEM
K121541
Implanet, S.A.
Orthopedic · 112d
Cleared Jul 03, 2012
SPINAL ELEMENTS CERCLAGE SYSTEM
K120177
Spinal Elements, Inc.
Orthopedic · 165d
Cleared Feb 01, 2012
PASS LP SPINAL
K112736
Medicrea International
Orthopedic · 134d
Cleared Jul 28, 2011
SYNTHES STERNAL ZIPFIX SYSTEM
K110789
Synthes (Usa)
Orthopedic · 128d
Cleared Jul 06, 2011
FIGURE 8 STERNOTOMY CLOSURE DEVICE
K110541
Figure 8 Surgical, Incorporated
Orthopedic · 131d
Cleared May 20, 2011
K2M COCR WIRE
K103797
K2m, Inc.
Orthopedic · 144d
Cleared May 03, 2011
BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
K110039
Biomet Sports Medicine
Orthopedic · 117d
Cleared Apr 01, 2011
COMPRESSYN BAND
K101484
Dallen Medical
Orthopedic · 308d
Cleared Jan 12, 2011
ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)
K102834
Kinamed, Incorporated
Orthopedic · 105d
Cleared Dec 08, 2009
SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS
K090686
Sic Brevetti S.R.L.
Orthopedic · 267d
Cleared Jul 30, 2009
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
K091190
Zimmer Spine, Inc.
Orthopedic · 98d
Cleared Aug 29, 2008
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM
K081622
Abbott Spine, Inc.
Orthopedic · 80d
Cleared Jul 01, 2008
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
K081205
Synthes (Usa)
Orthopedic · 63d