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
Jun 26, 1987
MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM
Howmedica Corp.
Orthopedic
17d
Cleared
Mar 19, 1987
RICHARDS EXTERNAL FIXATION SYSTEM
Richards Medical Co., Inc.
Orthopedic
9d
Cleared
Jul 25, 1986
SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN
Warsaw Orthopedic, Inc.
Orthopedic
38d
Cleared
Apr 15, 1986
DEPUY COMPRESSION HIP SCREW SYSTEM
Depuy, Inc.
Orthopedic
15d
Cleared
Nov 19, 1985
KIRSCHNER COMPRESSION HIP SCREW SYSTEM
Kirschner Medical Corp.
Orthopedic
34d
Cleared
Jul 15, 1985
MEC DISTAL FEMORAL BOLT
Pfizer, Inc.
Orthopedic
164d
Cleared
Jul 15, 1985
MEC HIP BOLT
Pfizer, Inc.
Orthopedic
161d
Cleared
Jul 15, 1985
MEC ROD CONNECTOR
Pfizer, Inc.
Orthopedic
160d
Cleared
Jun 28, 1985
SUPRACONDYLAR BONE PLATE
Warsaw Orthopedic, Inc.
Orthopedic
57d
Cleared
Jun 21, 1985
TROCHANTER CABLE GRIP SYSTEM
Howmedica Corp.
Orthopedic
246d
Cleared
Sep 25, 1984
T.O.D. PLATE SYSTEM
Kirschner Medical Corp.
Orthopedic
77d
Cleared
Sep 25, 1984
T.O.D. PLATE SYS STERILE
Kirschner Medical Corp.
Orthopedic
76d
Cleared
Sep 21, 1984
ACE/FISHER EXTERNAL FIXATOR
Buckman Co., Inc.
Orthopedic
67d
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
May 27, 1981
HUCKSTEP INTRAMEDULLARY NAIL
Downs Surgical , Ltd.
Orthopedic
42d
Cleared
Aug 28, 1979
DYNAMIC HIP SCREW
Synthes (Usa)
Orthopedic
7d
Cleared
Apr 10, 1979
PEDIATRIC OSTEOTOMY SYSTEM
Howmedica Corp.
Orthopedic
28d