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, Synthes (Usa) and Howmedica Corp..

130
Total
130
Cleared
131d
Avg days
1984
Since
130 devices
25–48 of 130
Cleared Jan 27, 2014
PERI-PROSTHETIC CABLE SYSTEM
K133354
Biomet, Inc.
Orthopedic · 88d
Cleared Jul 03, 2012
SPINAL ELEMENTS CERCLAGE SYSTEM
K120177
Spinal Elements, Inc.
Orthopedic · 165d
Cleared Jul 28, 2011
SYNTHES STERNAL ZIPFIX SYSTEM
K110789
Synthes (Usa)
Orthopedic · 128d
Cleared May 20, 2011
K2M COCR WIRE
K103797
K2m, Inc.
Orthopedic · 144d
Cleared Jul 30, 2009
UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
K091190
Zimmer Spine, Inc.
Orthopedic · 98d
Cleared Jul 01, 2008
SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
K081205
Synthes (Usa)
Orthopedic · 63d
Cleared Dec 27, 2006
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
K063017
Aesculap, Inc.
Orthopedic · 86d
Cleared Feb 25, 2005
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
K050041
Synthes (Usa)
Orthopedic · 49d
Cleared Jan 14, 2005
CABLING SYSTEM TROCHANTER HOOK
K043252
Smith & Nephew, Inc.
Orthopedic · 52d
Cleared Mar 02, 2004
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
K033816
Synthes (Usa)
Orthopedic · 84d
Cleared May 30, 2003
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
K031508
Synthes (Usa)
Orthopedic · 16d
Cleared May 01, 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared Jun 27, 2001
SYNTHES STERNAL FIXATION SYSTEM
K010943
Synthes (Usa)
Orthopedic · 90d
Cleared Oct 06, 2000
SPL CRIMP SYSTEM
K002110
Pioneer Surgical Technology
Orthopedic · 86d
Cleared Aug 31, 2000
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
K001709
Pioneer Surgical Technology
Orthopedic · 87d
Cleared Nov 23, 1999
PIONEER SILICOAT STERNAL CABLE
K993286
Pioneer Surgical Technology
Orthopedic · 53d
Cleared Nov 02, 1999
SYNTHES CERCLAGE POSITIONING PIN
K992891
Synthes (Usa)
Orthopedic · 67d
Cleared Oct 27, 1999
SDB CERCLAGE SYSTEM
K992616
Pioneer Surgical Technology
Orthopedic · 84d
Cleared Feb 24, 1999
DALL-MILES CABLE GRIP (A-GRIP)
K984432
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Oct 19, 1998
BMP CABLE SYSTEM
K982545
Biomet, Inc.
Orthopedic · 90d
Cleared May 22, 1998
CABLE SCREW WITH INTEGRAL CRIMP
K980690
Pioneer Surgical Technology
Orthopedic · 88d
Cleared Dec 19, 1997
CERCLAGE CABLE WITH HEX BUTTON
K974016
Pioneer Surgical Technology
Orthopedic · 58d
Cleared Oct 27, 1997
COMPRESSION CERCLAGE GUNDOLF CCG-GF
K973098
Plus Orthopedics
Orthopedic · 69d
Cleared Jul 16, 1997
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE
K971741
Howmedica Corp.
Orthopedic · 65d