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
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
Jun 27, 2001
SYNTHES STERNAL FIXATION SYSTEM
Synthes (Usa)
Orthopedic
90d
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
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
Cleared
May 22, 1998
CABLE SCREW WITH INTEGRAL CRIMP
Pioneer Surgical Technology
Orthopedic
88d
Cleared
Dec 19, 1997
CERCLAGE CABLE WITH HEX BUTTON
Pioneer Surgical Technology
Orthopedic
58d
Cleared
Dec 19, 1997
SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM
Spinal Concepts, Inc.
Orthopedic
58d
Cleared
Oct 27, 1997
COMPRESSION CERCLAGE GUNDOLF CCG-GF
Plus Orthopedics
Orthopedic
69d
Cleared
Aug 11, 1997
METAGEN ACTIVELOCK CERCLAGE SYSTEM
Pacific Materials and Interfaces
Orthopedic
49d
Cleared
Jul 16, 1997
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE
Howmedica Corp.
Orthopedic
65d
Cleared
Mar 13, 1997
LINK CERCLAGE WIRE SYSTEM
Turnkey Intergration USA, Inc.
Orthopedic
63d
Cleared
Aug 14, 1996
DALL-MILES TROCHANTER CABLE SUPERGRIP
Howmedica Corp.
Orthopedic
71d
Cleared
Aug 08, 1996
SILKON STAINLESS STEEL CABLE SYSTEM
Osteonics Corp.
Orthopedic
66d
Cleared
Jun 27, 1996
PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE
Pioneer Surgical Technology
Orthopedic
86d
Cleared
Jun 24, 1996
DALL-MILES STAINLESS STEEL BEADED CABLE
Howmedica Corp.
Orthopedic
62d