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
Jul 14, 1992
MONOTUBE EXTERNAL FIXATION SYSTEM
Howmedica Corp.
Orthopedic
524d
Cleared
Jan 21, 1992
RIHARDS TITANIUM HALF PIN
Smith & Nephew Richards, Inc.
Orthopedic
19d
Cleared
Jan 16, 1992
HOFFMANN DYNAMIC WRIST FIXATOR
Howmedica Corp.
Orthopedic
315d
Cleared
Jan 16, 1992
TRAUMAFIX (TM) EXTERNAL FIXATOR
Synthes (Usa)
Orthopedic
93d
Cleared
Aug 14, 1991
INTRAMEDULLARY HIP SCREW, MODIFICATION
Smith & Nephew Richards, Inc.
Orthopedic
90d
Cleared
Apr 02, 1991
AUTOGENESIS(TM) AUTOMATOR
Advanced Biosearch Assn.
Orthopedic
116d
Cleared
Dec 11, 1990
SIDE PLATE
O'Tec Corp.
Orthopedic
13d
Cleared
Dec 11, 1990
LAG SCREW
O'Tec Corp.
Orthopedic
13d
Cleared
Dec 11, 1990
JEWETT HIP NAIL
O'Tec Corp.
Orthopedic
13d
Cleared
Dec 11, 1990
BLADE PLATE
O'Tec Corp.
Orthopedic
13d
Cleared
Oct 04, 1990
KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE
Kirschner Medical Corp.
Orthopedic
204d
Cleared
Jul 30, 1990
SIDE PLATE
Onyx Medical Corp.
Orthopedic
6d
Cleared
Jul 30, 1990
BLADE PLATE
Onyx Medical Corp.
Orthopedic
6d
Cleared
Jul 30, 1990
JEWETT HIP NAIL
Onyx Medical Corp.
Orthopedic
6d
Cleared
Apr 18, 1990
ALTA LAG SCREW AND COMPRESSION SCREW
Howmedica Corp.
Orthopedic
70d
Cleared
Apr 05, 1990
DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR
Origin Medsystems, Inc.
Orthopedic
401d
Cleared
Mar 13, 1990
LINK GIEBEL BLADE PLATE SYSTEM
Link America, Inc.
Orthopedic
183d
Cleared
Jan 04, 1990
INTRAMEDULLARY HIP SCREW
Richards Medical Co., Inc.
Orthopedic
136d
Cleared
Aug 28, 1989
DANEK WRIST FIXATOR
Danek Medical, Inc.
Orthopedic
180d
Cleared
Aug 03, 1989
GAMMA LOCKING NAIL
Howmedica Corp.
Orthopedic
83d
Cleared
Jun 13, 1989
DANEK RING FIXATOR (DRF)
Danek Medical, Inc.
Orthopedic
117d
Cleared
Sep 22, 1988
TECHMEDICA MP SYSTEM
Techmedica, Inc.
Orthopedic
71d
Cleared
Oct 28, 1987
ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT
Howmedica Corp.
Orthopedic
61d
Cleared
Aug 17, 1987
MODIFIED TROCHANTER CABLE GRIP SYSTEM
Howmedica Corp.
Orthopedic
69d