KTT · Class II · 21 CFR 888.3030

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
337–360 of 404
Cleared Jun 26, 1987
MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM
K872223
Howmedica Corp.
Orthopedic · 17d
Cleared Mar 19, 1987
RICHARDS EXTERNAL FIXATION SYSTEM
K870961
Richards Medical Co., Inc.
Orthopedic · 9d
Cleared Jul 25, 1986
SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN
K862311
Warsaw Orthopedic, Inc.
Orthopedic · 38d
Cleared Apr 15, 1986
DEPUY COMPRESSION HIP SCREW SYSTEM
K861178
Depuy, Inc.
Orthopedic · 15d
Cleared Nov 19, 1985
KIRSCHNER COMPRESSION HIP SCREW SYSTEM
K854205
Kirschner Medical Corp.
Orthopedic · 34d
Cleared Jul 15, 1985
MEC DISTAL FEMORAL BOLT
K850403
Pfizer, Inc.
Orthopedic · 164d
Cleared Jul 15, 1985
MEC HIP BOLT
K850413
Pfizer, Inc.
Orthopedic · 161d
Cleared Jul 15, 1985
MEC ROD CONNECTOR
K850443
Pfizer, Inc.
Orthopedic · 160d
Cleared Jun 28, 1985
SUPRACONDYLAR BONE PLATE
K851919
Warsaw Orthopedic, Inc.
Orthopedic · 57d
Cleared Jun 21, 1985
TROCHANTER CABLE GRIP SYSTEM
K844068
Howmedica Corp.
Orthopedic · 246d
Cleared Sep 25, 1984
T.O.D. PLATE SYSTEM
K842681
Kirschner Medical Corp.
Orthopedic · 77d
Cleared Sep 25, 1984
T.O.D. PLATE SYS STERILE
K842695
Kirschner Medical Corp.
Orthopedic · 76d
Cleared Sep 21, 1984
ACE/FISHER EXTERNAL FIXATOR
K842768
Buckman Co., Inc.
Orthopedic · 67d
Cleared Mar 25, 1983
CORSTREN COMPRESSION TUBE & PLATE
K830196
Zimmer, Inc.
Orthopedic · 64d
Cleared Dec 28, 1982
COMPRESSION HIP SCREW SIDE-PLATE
K823548
Howmedica Corp.
Orthopedic · 28d
Cleared May 27, 1981
HUCKSTEP INTRAMEDULLARY NAIL
K811017
Downs Surgical , Ltd.
Orthopedic · 42d
Cleared Aug 28, 1979
DYNAMIC HIP SCREW
K791619
Synthes (Usa)
Orthopedic · 7d
Cleared Apr 10, 1979
PEDIATRIC OSTEOTOMY SYSTEM
K790501
Howmedica Corp.
Orthopedic · 28d