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
73–96 of 131
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 Dec 19, 1997
SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM
K974020
Spinal Concepts, Inc.
Orthopedic · 58d
Cleared Oct 27, 1997
COMPRESSION CERCLAGE GUNDOLF CCG-GF
K973098
Plus Orthopedics
Orthopedic · 69d
Cleared Aug 11, 1997
METAGEN ACTIVELOCK CERCLAGE SYSTEM
K972327
Pacific Materials and Interfaces
Orthopedic · 49d
Cleared Jul 16, 1997
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE
K971741
Howmedica Corp.
Orthopedic · 65d
Cleared Mar 13, 1997
LINK CERCLAGE WIRE SYSTEM
K970084
Turnkey Intergration USA, Inc.
Orthopedic · 63d
Cleared Aug 14, 1996
DALL-MILES TROCHANTER CABLE SUPERGRIP
K962162
Howmedica Corp.
Orthopedic · 71d
Cleared Aug 08, 1996
SILKON STAINLESS STEEL CABLE SYSTEM
K962132
Osteonics Corp.
Orthopedic · 66d
Cleared Jun 27, 1996
PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE
K961267
Pioneer Surgical Technology
Orthopedic · 86d
Cleared Jun 24, 1996
DALL-MILES STAINLESS STEEL BEADED CABLE
K961569
Howmedica Corp.
Orthopedic · 62d
Cleared May 22, 1996
DALL-MILES HOMOGENOUS VITALLIUM CABLE
K961283
Howmedica Corp.
Orthopedic · 49d
Cleared May 03, 1996
CERCLAGE WIRE CRIMP BLOCK
K960651
Acu Med, Inc.
Orthopedic · 78d
Cleared Mar 08, 1996
SYNTHES WIRE MOUNT
K953777
Synthes (Usa)
Orthopedic · 207d
Cleared Oct 12, 1995
DALL-MILES SUTURE/BEADED CABLE
K953818
Howmedica Corp.
Orthopedic · 58d
Cleared Jul 13, 1995
BIOMECHANIC LOW-PROFILE CABLE SYSTEM
K951844
Biomechanic, Inc.
Orthopedic · 84d
Cleared Mar 07, 1995
DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE
K945294
Howmedica Corp.
Orthopedic · 127d
Cleared Mar 06, 1995
CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK
K950027
Intermedics Orthopedics
Orthopedic · 61d
Cleared Feb 17, 1995
CABLE-EASE PLATE AND CABLE SYSTEM
K944529
Intermedics Orthopedics
Orthopedic · 155d
Cleared Feb 14, 1995
CCG CERCLAGE SYSTEM
K932024
Encore Orthopedics, Inc.
Orthopedic · 659d
Cleared Jan 09, 1995
SILKON TITANIUM CABLE SYSTEM
K942300
American Medical Electronics, Inc.
Orthopedic · 242d
Cleared Dec 21, 1994
PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES
K940729
Pioneer Surgical Technology
Orthopedic · 306d
Cleared Aug 01, 1994
DALL MILES SYSTEM GROOVED BUTTON
K934059
Howmedica Corp.
Orthopedic · 347d
Cleared May 03, 1994
AME(R) UNIVERSIAL CABLE SYSTEM
K932687
American Medical Electronics, Inc.
Orthopedic · 334d