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
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 28, 1996
EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS
Electro-Biology, Inc.
Orthopedic
74d
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
Mar 18, 1996
PRACTIFIX EXTERNAL FIXATION SYSTEM
Orthopaedic Innovations, Inc.
Orthopedic
76d
Cleared
Jan 26, 1996
VERSA-FX FEMORAL FIXATION SYSTEM
Zimmer, Inc.
Orthopedic
116d
Cleared
Oct 31, 1995
EBI X FIX DYNAFIX SYSTEM (DFS)
Electro-Biology, Inc.
Orthopedic
103d
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
Jun 21, 1995
EBI SMALL EXTERNAL FIXATOR (S/E/F/)
Electro-Biology, Inc.
Orthopedic
89d
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
Sep 28, 1994
ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW
Alphatec Mfg., Inc.
Orthopedic
644d
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
Cleared
Sep 08, 1992
OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION
Howmedica Corp.
Orthopedic
116d
Cleared
Jul 17, 1992
INTRAMEDULLARY HIP SCREW
Smith & Nephew Richards, Inc.
Orthopedic
94d