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 Synthes (Usa), Howmedica Corp. and Howmedica Osteonics Corp..
403
Total
403
Cleared
107d
Avg days
1979
Since
403 devices
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 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 14, 1992
MONOTUBE EXTERNAL FIXATION SYSTEM
Howmedica Corp.
Orthopedic
524d
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
Apr 18, 1990
ALTA LAG SCREW AND COMPRESSION SCREW
Howmedica Corp.
Orthopedic
70d
Cleared
Aug 03, 1989
GAMMA LOCKING NAIL
Howmedica Corp.
Orthopedic
83d
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
Cleared
Jun 26, 1987
MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM
Howmedica Corp.
Orthopedic
17d
Cleared
Apr 15, 1986
DEPUY COMPRESSION HIP SCREW SYSTEM
Depuy, Inc.
Orthopedic
15d
Cleared
Jun 21, 1985
TROCHANTER CABLE GRIP SYSTEM
Howmedica Corp.
Orthopedic
246d
Cleared
Mar 25, 1983
CORSTREN COMPRESSION TUBE & PLATE
Zimmer, Inc.
Orthopedic
64d
Cleared
Dec 28, 1982
COMPRESSION HIP SCREW SIDE-PLATE
Howmedica Corp.
Orthopedic
28d
Cleared
Aug 28, 1979
DYNAMIC HIP SCREW
Synthes (Usa)
Orthopedic
7d
Cleared
Apr 10, 1979
PEDIATRIC OSTEOTOMY SYSTEM
Howmedica Corp.
Orthopedic
28d