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..

130
Total
130
Cleared
131d
Avg days
1984
Since
130 devices
49–72 of 130
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 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 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 Apr 19, 1994
SONGER CABLE SYSTEM
K941213
Pioneer Surgical Technology
Orthopedic · 41d
Cleared Mar 09, 1994
FX-CABLELOK CABLE/PLATE SYSTEM
K935950
Buckman Co., Inc.
Orthopedic · 86d
Cleared Feb 25, 1994
CONTROL CABLE SYSTEM
K934557
Depuy, Inc.
Orthopedic · 162d
Cleared Feb 23, 1994
DALL MILES SYSTEM MINICLEAT
K934058
Howmedica Corp.
Orthopedic · 188d
Cleared Feb 22, 1994
CERCLAGE WIRE CRIMP SLEEVE
K931246
Acu Med, Inc.
Orthopedic · 348d
Cleared Jan 26, 1994
SPONGER CABLE SYSTEM, MODIFICATION
K935481
Pioneer Surgical Technology
Orthopedic · 125d
Cleared Nov 30, 1993
ORTHOPAEDIC POLYETHYLENE CABLE
K924141
Smith & Nephew Richards, Inc.
Orthopedic · 469d
Cleared May 12, 1993
CODMAN SOF'WIRE TITANIUM CABLE SYSTEM
K923869
Codman & Shurtleff, Inc.
Orthopedic · 282d
Cleared Mar 30, 1993
CODMAN SOFWIRE(TM) KIT
K926116
Codman & Shurtleff, Inc.
Orthopedic · 117d
Cleared Feb 23, 1993
SONGER CABLE SYSTEM
K922952
Pioneer Surgical Technology
Orthopedic · 250d