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
Cleared
Nov 20, 1997
HOFFMANN II COMPACT PERIARTICULAR CLAMP
Howmedica, Inc.
Orthopedic
77d
Cleared
Oct 16, 1997
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
Synthes (Usa)
Orthopedic
64d
Cleared
Oct 09, 1997
DEPUY AE TK2 HIP SCREW SYSTEM
Depuy, Inc.
Orthopedic
87d
Cleared
Apr 01, 1997
EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM
Ebi, L.P.
Orthopedic
67d
Cleared
Jan 22, 1997
MEDOFF SLIDING PLATE (PROPOSED NAME)
Wrightmedicaltechnologyinc
Orthopedic
224d
Cleared
Nov 27, 1996
MINIFIX
Ferguson Medical
Orthopedic
47d
Cleared
Sep 05, 1996
SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)
Synthes (Usa)
Orthopedic
71d
Cleared
Aug 19, 1996
ILIZAROV EXTERNAL FIXATION SYSTEM
Smith & Nephew Richards, Inc.
Orthopedic
32d
Cleared
Jun 28, 1996
SYNTHES MINI EXTERNAL FIXATOR
Synthes (Usa)
Orthopedic
84d
Cleared
Jun 13, 1996
ALTA DOME AND PLUNGER (MEC HIP BOLT)
Howmedica Corp.
Orthopedic
77d
Cleared
Apr 10, 1996
OMEGA+ COMPRESSION SCREW SYSTEM
Howmedica Corp.
Orthopedic
142d
Cleared
Jan 26, 1996
VERSA-FX FEMORAL FIXATION SYSTEM
Zimmer, Inc.
Orthopedic
116d
Cleared
Oct 31, 1995
INTRAMEDULLARY HIP SCREW (MODIFICATION)
Smith & Nephew Richards, Inc.
Orthopedic
76d
Cleared
Jul 13, 1995
GLIDING NAIL
Encore Orthopedics, Inc.
Orthopedic
86d
Cleared
May 03, 1995
DEPUY COMPRESSION HIP SCREW SYSTEM
Depuy, Inc.
Orthopedic
138d
Cleared
Feb 01, 1995
PEDIATRIC OSTEOTOMY SYSTEM
Howmedica Corp.
Orthopedic
121d
Cleared
Jan 18, 1995
HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM
Howmedica Corp.
Orthopedic
700d
Cleared
Nov 28, 1994
GAMMA LOCKING NAIL - LONG LENGTH
Howmedica Corp.
Orthopedic
56d
Cleared
Mar 14, 1994
GAMMA LOCKING NAIL MODIFICATION
Howmedica, Inc.
Orthopedic
63d
Cleared
Mar 10, 1994
SYNTHES STERILE PINLESS EXTERNAL FIXATOR
Synthes (Usa)
Orthopedic
497d
Cleared
Mar 07, 1994
GAMMA LOCKING NAIL-CROSS LOCKING SCREWS
Howmedica Corp.
Orthopedic
306d
Cleared
Oct 01, 1993
CAP WASHER ASSEMBLY
Howmedica Corp.
Orthopedic
658d
Cleared
Mar 22, 1993
ALTA CANCELLOUS BONE SCREW
Howmedica Corp.
Orthopedic
160d
Cleared
Nov 25, 1992
MORREY ELBOW FIXATOR
Howmedica Corp.
Orthopedic
629d