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..

131
Total
131
Cleared
131d
Avg days
1984
Since
131 devices
49–72 of 131
Cleared Oct 23, 2007
BIOMET CABLE SYSTEM
K071271
Biomet Manufacturing, Inc.
Orthopedic · 169d
Cleared Dec 27, 2006
AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
K063017
Aesculap, Inc.
Orthopedic · 86d
Cleared Mar 06, 2006
ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
K060009
Abbott Spine, Inc.
Orthopedic · 62d
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 Feb 20, 2004
OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS
K040199
Osseus, LLC
Orthopedic · 22d
Cleared Oct 21, 2003
ISO-ELASTIC CERCLAGE SYSTEM
K030256
Kinamed, Inc.
Orthopedic · 270d
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 Mar 11, 2003
OSSE-LIGN
K023564
Osseus, LLC
Orthopedic · 139d
Cleared Jun 27, 2001
SYNTHES STERNAL FIXATION SYSTEM
K010943
Synthes (Usa)
Orthopedic · 90d
Cleared Mar 21, 2001
PECTOFIX STERNAL REPAIR WIRE
K003951
Pectofix, Inc.
Orthopedic · 90d
Cleared Dec 13, 2000
ORTHOMATRIX, INC. CERCLAGE SYSTEM
K001254
Orthomatrix, Inc.
Orthopedic · 238d
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 May 11, 2000
PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)
K000694
Pectofix, Inc.
Orthopedic · 71d
Cleared Feb 14, 2000
WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
K993903
Whiteside Biomechanics, Inc.
Orthopedic · 90d
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 Dec 30, 1998
METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM
K983976
Metagen, LLC
Orthopedic · 51d
Cleared Oct 19, 1998
BMP CABLE SYSTEM
K982545
Biomet, Inc.
Orthopedic · 90d