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
313–336 of 404
Cleared Jul 14, 1992
MONOTUBE EXTERNAL FIXATION SYSTEM
K910483
Howmedica Corp.
Orthopedic · 524d
Cleared Jan 21, 1992
RIHARDS TITANIUM HALF PIN
K920024
Smith & Nephew Richards, Inc.
Orthopedic · 19d
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 Aug 14, 1991
INTRAMEDULLARY HIP SCREW, MODIFICATION
K912162
Smith & Nephew Richards, Inc.
Orthopedic · 90d
Cleared Apr 02, 1991
AUTOGENESIS(TM) AUTOMATOR
K905514
Advanced Biosearch Assn.
Orthopedic · 116d
Cleared Dec 11, 1990
SIDE PLATE
K905338
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
LAG SCREW
K905342
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
JEWETT HIP NAIL
K905346
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
BLADE PLATE
K905352
O'Tec Corp.
Orthopedic · 13d
Cleared Oct 04, 1990
KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE
K901234
Kirschner Medical Corp.
Orthopedic · 204d
Cleared Jul 30, 1990
SIDE PLATE
K903246
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
BLADE PLATE
K903250
Onyx Medical Corp.
Orthopedic · 6d
Cleared Jul 30, 1990
JEWETT HIP NAIL
K903251
Onyx Medical Corp.
Orthopedic · 6d
Cleared Apr 18, 1990
ALTA LAG SCREW AND COMPRESSION SCREW
K900584
Howmedica Corp.
Orthopedic · 70d
Cleared Apr 05, 1990
DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR
K890989
Origin Medsystems, Inc.
Orthopedic · 401d
Cleared Mar 13, 1990
LINK GIEBEL BLADE PLATE SYSTEM
K895507
Link America, Inc.
Orthopedic · 183d
Cleared Jan 04, 1990
INTRAMEDULLARY HIP SCREW
K895241
Richards Medical Co., Inc.
Orthopedic · 136d
Cleared Aug 28, 1989
DANEK WRIST FIXATOR
K891066
Danek Medical, Inc.
Orthopedic · 180d
Cleared Aug 03, 1989
GAMMA LOCKING NAIL
K893639
Howmedica Corp.
Orthopedic · 83d
Cleared Jun 13, 1989
DANEK RING FIXATOR (DRF)
K890814
Danek Medical, Inc.
Orthopedic · 117d
Cleared Sep 22, 1988
TECHMEDICA MP SYSTEM
K882922
Techmedica, Inc.
Orthopedic · 71d
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