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, Howmedica Corp. and Synthes (Usa).

130
Total
130
Cleared
131d
Avg days
1984
Since
130 devices
49–72 of 130
Cleared Oct 21, 2003
ISO-ELASTIC CERCLAGE SYSTEM
K030256
Kinamed, Inc.
Orthopedic · 270d
Cleared May 30, 2003
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
K031508
Synthes (Usa)
Orthopedic · 16d
Cleared May 01, 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162
Smith & Nephew, Inc.
Orthopedic · 17d
Cleared Jun 27, 2001
SYNTHES STERNAL FIXATION SYSTEM
K010943
Synthes (Usa)
Orthopedic · 90d
Cleared Oct 06, 2000
SPL CRIMP SYSTEM
K002110
Pioneer Surgical Technology
Orthopedic · 86d
Cleared Aug 31, 2000
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
K001709
Pioneer Surgical Technology
Orthopedic · 87d
Cleared Feb 14, 2000
WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
K993903
Whiteside Biomechanics, Inc.
Orthopedic · 90d
Cleared Nov 23, 1999
PIONEER SILICOAT STERNAL CABLE
K993286
Pioneer Surgical Technology
Orthopedic · 53d
Cleared Nov 02, 1999
SYNTHES CERCLAGE POSITIONING PIN
K992891
Synthes (Usa)
Orthopedic · 67d
Cleared Oct 27, 1999
SDB CERCLAGE SYSTEM
K992616
Pioneer Surgical Technology
Orthopedic · 84d
Cleared Feb 24, 1999
DALL-MILES CABLE GRIP (A-GRIP)
K984432
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Dec 30, 1998
METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM
K983976
Metagen, LLC
Orthopedic · 51d
Cleared Oct 19, 1998
BMP CABLE SYSTEM
K982545
Biomet, Inc.
Orthopedic · 90d
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