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 Synthes (Usa), Howmedica Corp. and Howmedica Osteonics Corp..

403
Total
403
Cleared
107d
Avg days
1979
Since
403 devices
145–168 of 403
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 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 14, 1992
MONOTUBE EXTERNAL FIXATION SYSTEM
K910483
Howmedica Corp.
Orthopedic · 524d
Cleared Jan 16, 1992
HOFFMANN DYNAMIC WRIST FIXATOR
K910986
Howmedica Corp.
Orthopedic · 315d
Cleared Jan 16, 1992
TRAUMAFIX (TM) EXTERNAL FIXATOR
K914558
Synthes (Usa)
Orthopedic · 93d
Cleared Apr 18, 1990
ALTA LAG SCREW AND COMPRESSION SCREW
K900584
Howmedica Corp.
Orthopedic · 70d
Cleared Aug 03, 1989
GAMMA LOCKING NAIL
K893639
Howmedica Corp.
Orthopedic · 83d
Cleared Oct 28, 1987
ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT
K873459
Howmedica Corp.
Orthopedic · 61d
Cleared Aug 17, 1987
MODIFIED TROCHANTER CABLE GRIP SYSTEM
K872224
Howmedica Corp.
Orthopedic · 69d
Cleared Jun 26, 1987
MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM
K872223
Howmedica Corp.
Orthopedic · 17d
Cleared Apr 15, 1986
DEPUY COMPRESSION HIP SCREW SYSTEM
K861178
Depuy, Inc.
Orthopedic · 15d
Cleared Jun 21, 1985
TROCHANTER CABLE GRIP SYSTEM
K844068
Howmedica Corp.
Orthopedic · 246d
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 Aug 28, 1979
DYNAMIC HIP SCREW
K791619
Synthes (Usa)
Orthopedic · 7d
Cleared Apr 10, 1979
PEDIATRIC OSTEOTOMY SYSTEM
K790501
Howmedica Corp.
Orthopedic · 28d