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
289–312 of 404
Cleared Aug 19, 1996
ILIZAROV EXTERNAL FIXATION SYSTEM
K962808
Smith & Nephew Richards, Inc.
Orthopedic · 32d
Cleared Jun 28, 1996
SYNTHES MINI EXTERNAL FIXATOR
K961350
Synthes (Usa)
Orthopedic · 84d
Cleared Jun 28, 1996
EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS
K961433
Electro-Biology, Inc.
Orthopedic · 74d
Cleared Jun 13, 1996
ALTA DOME AND PLUNGER (MEC HIP BOLT)
K961213
Howmedica Corp.
Orthopedic · 77d
Cleared Apr 10, 1996
OMEGA+ COMPRESSION SCREW SYSTEM
K955306
Howmedica Corp.
Orthopedic · 142d
Cleared Mar 18, 1996
PRACTIFIX EXTERNAL FIXATION SYSTEM
K960014
Orthopaedic Innovations, Inc.
Orthopedic · 76d
Cleared Jan 26, 1996
VERSA-FX FEMORAL FIXATION SYSTEM
K954555
Zimmer, Inc.
Orthopedic · 116d
Cleared Oct 31, 1995
EBI X FIX DYNAFIX SYSTEM (DFS)
K953406
Electro-Biology, Inc.
Orthopedic · 103d
Cleared Oct 31, 1995
INTRAMEDULLARY HIP SCREW (MODIFICATION)
K954712
Smith & Nephew Richards, Inc.
Orthopedic · 76d
Cleared Jul 13, 1995
GLIDING NAIL
K951809
Encore Orthopedics, Inc.
Orthopedic · 86d
Cleared Jun 21, 1995
EBI SMALL EXTERNAL FIXATOR (S/E/F/)
K951357
Electro-Biology, Inc.
Orthopedic · 89d
Cleared May 03, 1995
DEPUY COMPRESSION HIP SCREW SYSTEM
K946156
Depuy, Inc.
Orthopedic · 138d
Cleared Feb 01, 1995
PEDIATRIC OSTEOTOMY SYSTEM
K945233
Howmedica Corp.
Orthopedic · 121d
Cleared Jan 18, 1995
HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM
K930836
Howmedica Corp.
Orthopedic · 700d
Cleared Nov 28, 1994
GAMMA LOCKING NAIL - LONG LENGTH
K944883
Howmedica Corp.
Orthopedic · 56d
Cleared Sep 28, 1994
ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW
K926417
Alphatec Mfg., Inc.
Orthopedic · 644d
Cleared Mar 14, 1994
GAMMA LOCKING NAIL MODIFICATION
K940286
Howmedica, Inc.
Orthopedic · 63d
Cleared Mar 10, 1994
SYNTHES STERILE PINLESS EXTERNAL FIXATOR
K925460
Synthes (Usa)
Orthopedic · 497d
Cleared Mar 07, 1994
GAMMA LOCKING NAIL-CROSS LOCKING SCREWS
K932174
Howmedica Corp.
Orthopedic · 306d
Cleared Oct 01, 1993
CAP WASHER ASSEMBLY
K915599
Howmedica Corp.
Orthopedic · 658d
Cleared Mar 22, 1993
ALTA CANCELLOUS BONE SCREW
K925127
Howmedica Corp.
Orthopedic · 160d
Cleared Nov 25, 1992
MORREY ELBOW FIXATOR
K910993
Howmedica Corp.
Orthopedic · 629d
Cleared Sep 08, 1992
OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION
K922295
Howmedica Corp.
Orthopedic · 116d
Cleared Jul 17, 1992
INTRAMEDULLARY HIP SCREW
K921786
Smith & Nephew Richards, Inc.
Orthopedic · 94d