KTT · Class II · 21 CFR 888.3030

FDA Product Code KTT: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

Under FDA product code KTT, nail/blade/plate combination fixation appliances are cleared for the treatment of peritrochanteric and subtrochanteric hip fractures.

These hybrid implants combine an intramedullary nail or blade with a plate component to provide both axial and rotational stability at the fracture site. They are the standard of care for unstable intertrochanteric femur fractures in elderly patients.

KTT devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Ebi, L.P., Synthes (Usa) and Howmedica Corp..

404
Total
404
Cleared
107d
Avg days
1979
Since
404 devices
265–288 of 404
Cleared Nov 19, 1999
EBI XFIX DFS WRISTFIX SYSTEM
K993649
Ebi, L.P.
Orthopedic · 21d
Cleared Aug 19, 1999
EBI XFIX DFS RAIL SYSTEM
K991941
Electro-Biology, Inc.
Orthopedic · 71d
Cleared Aug 17, 1999
EBI XFIX DFS OPTIROM ELBOW FIXATOR
K992515
Ebi, L.P.
Orthopedic · 20d
Cleared Aug 06, 1999
VHS SUPRACONDYLAR PLATE SYSTEM
K991806
Walter Abendschein, M.D.
Orthopedic · 72d
Cleared Mar 02, 1999
SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820
K984364
Syntec Scientific Corp.
Orthopedic · 85d
Cleared Feb 18, 1999
SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM
K984498
Synthes (Usa)
Orthopedic · 63d
Cleared Dec 30, 1998
SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM
K983873
Syntec Scientific Corp.
Orthopedic · 58d
Cleared Jul 08, 1998
EBI DFS JOINT FIXATOR, MODEL 02800
K981483
Electro-Biology, Inc.
Orthopedic · 75d
Cleared Apr 14, 1998
BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR
K980370
Biomet, Inc.
Orthopedic · 74d
Cleared Feb 19, 1998
FRIEDL GLIDING NAIL SYSTEM
K974409
Plus Orthopedics
Orthopedic · 87d
Cleared Feb 18, 1998
SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM
K974537
Synthes (Usa)
Orthopedic · 77d
Cleared Nov 20, 1997
THE CORIFIX DYNAMIC HIP SCREW SYSTEM
K973231
Corin USA
Orthopedic · 85d
Cleared Nov 20, 1997
HOFFMANN II COMPACT PERIARTICULAR CLAMP
K973321
Howmedica, Inc.
Orthopedic · 77d
Cleared Nov 12, 1997
ODI COMPRESSION HIP SCREW SYSTEM
K971993
Orthopaedic Designs, Inc.
Orthopedic · 167d
Cleared Oct 16, 1997
VARI-ANGLE HIP SCREW (VHS) SYSTEM
K964880
Walter Abendschein, M.D.
Orthopedic · 315d
Cleared Oct 16, 1997
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
K973017
Synthes (Usa)
Orthopedic · 64d
Cleared Oct 09, 1997
DEPUY AE TK2 HIP SCREW SYSTEM
K972629
Depuy, Inc.
Orthopedic · 87d
Cleared May 09, 1997
TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM
K970748
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 67d
Cleared Apr 28, 1997
ALPHATEC EXTERNAL FIXATION SYSTEM
K964400
Alphatec Mfg., Inc.
Orthopedic · 175d
Cleared Apr 01, 1997
EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM
K970290
Ebi, L.P.
Orthopedic · 67d
Cleared Jan 22, 1997
MEDOFF SLIDING PLATE (PROPOSED NAME)
K962251
Wrightmedicaltechnologyinc
Orthopedic · 224d
Cleared Dec 09, 1996
ELLIS EXTERNAL MINI-FIXATOR SYSTEM
K964458
Link America, Inc.
Orthopedic · 32d
Cleared Nov 27, 1996
MINIFIX
K964094
Ferguson Medical
Orthopedic · 47d
Cleared Sep 05, 1996
SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)
K962484
Synthes (Usa)
Orthopedic · 71d