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
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
Cleared
May 22, 1996
DALL-MILES HOMOGENOUS VITALLIUM CABLE
Howmedica Corp.
Orthopedic
49d
Cleared
May 03, 1996
CERCLAGE WIRE CRIMP BLOCK
Acu Med, Inc.
Orthopedic
78d
Cleared
Mar 08, 1996
SYNTHES WIRE MOUNT
Synthes (Usa)
Orthopedic
207d
Cleared
Oct 12, 1995
DALL-MILES SUTURE/BEADED CABLE
Howmedica Corp.
Orthopedic
58d
Cleared
Jul 13, 1995
BIOMECHANIC LOW-PROFILE CABLE SYSTEM
Biomechanic, Inc.
Orthopedic
84d
Cleared
Mar 07, 1995
DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE
Howmedica Corp.
Orthopedic
127d
Cleared
Mar 06, 1995
CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK
Intermedics Orthopedics
Orthopedic
61d
Cleared
Feb 17, 1995
CABLE-EASE PLATE AND CABLE SYSTEM
Intermedics Orthopedics
Orthopedic
155d
Cleared
Feb 14, 1995
CCG CERCLAGE SYSTEM
Encore Orthopedics, Inc.
Orthopedic
659d
Cleared
Jan 09, 1995
SILKON TITANIUM CABLE SYSTEM
American Medical Electronics, Inc.
Orthopedic
242d
Cleared
Dec 21, 1994
PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES
Pioneer Surgical Technology
Orthopedic
306d
Cleared
Aug 01, 1994
DALL MILES SYSTEM GROOVED BUTTON
Howmedica Corp.
Orthopedic
347d
Cleared
May 03, 1994
AME(R) UNIVERSIAL CABLE SYSTEM
American Medical Electronics, Inc.
Orthopedic
334d