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
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
Mar 06, 2006
ABBOTT SPINE UNIVERSAL CLAMP SYSTEM
Abbott Spine, Inc.
Orthopedic
62d
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
Feb 20, 2004
OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS
Osseus, LLC
Orthopedic
22d
Cleared
Oct 21, 2003
ISO-ELASTIC CERCLAGE SYSTEM
Kinamed, Inc.
Orthopedic
270d
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
Mar 11, 2003
OSSE-LIGN
Osseus, LLC
Orthopedic
139d
Cleared
Jun 27, 2001
SYNTHES STERNAL FIXATION SYSTEM
Synthes (Usa)
Orthopedic
90d
Cleared
Mar 21, 2001
PECTOFIX STERNAL REPAIR WIRE
Pectofix, Inc.
Orthopedic
90d
Cleared
Dec 13, 2000
ORTHOMATRIX, INC. CERCLAGE SYSTEM
Orthomatrix, Inc.
Orthopedic
238d
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
May 11, 2000
PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)
Pectofix, Inc.
Orthopedic
71d
Cleared
Feb 14, 2000
WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
Whiteside Biomechanics, Inc.
Orthopedic
90d
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
Dec 30, 1998
METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM
Metagen, LLC
Orthopedic
51d
Cleared
Oct 19, 1998
BMP CABLE SYSTEM
Biomet, Inc.
Orthopedic
90d