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
97–120 of 404
Cleared Dec 08, 2014
ORTHOFIX GALAXY WRIST
K141760
Orthofix Srl
Orthopedic · 160d
Cleared Dec 05, 2014
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT
K142052
Orthofix Srl
Orthopedic · 130d
Cleared Nov 20, 2014
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
K142520
Smith & Nephew, Inc.
Orthopedic · 73d
Cleared Nov 10, 2014
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K140961
Stryker Trauma AG
Orthopedic · 209d
Cleared Oct 29, 2014
AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON
K141912
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 106d
Cleared Oct 10, 2014
INTEGRA EXTERNAL FIXATION SYSTEM
K140463
Ascension Orthopedic
Orthopedic · 228d
Cleared Sep 18, 2014
XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K141697
Zimmer, Inc.
Orthopedic · 86d
Cleared Sep 02, 2014
ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)
K141078
Orthofix Srl
Orthopedic · 130d
Cleared Jun 10, 2014
EMERGE EXTERNAL FIXATION SYSTEM
K140675
Emerge Medical, Inc.
Orthopedic · 84d
Cleared May 29, 2014
S.E.A.L. FRACTURE FUSION TUBE
K140158
Dne, LLC
Orthopedic · 127d
Cleared May 29, 2014
DRIVE RAIL SYSTEM
K140822
Devise Ortho, Inc.
Orthopedic · 58d
Cleared Jan 28, 2014
XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K131413
Zimmer, Inc.
Orthopedic · 257d
Cleared Jan 16, 2014
DOLPHIX EXTERNAL FIXATION SYSTEM
K132363
Citieffe S.R.L.
Orthopedic · 170d
Cleared Jun 10, 2013
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K130907
Stryker Trauma AG
Orthopedic · 70d
Cleared May 15, 2013
NBX - NON BRIDGING EXTERNAL FIXATOR HAND
K122777
Nutek Orthopaedics, Inc.
Orthopedic · 246d
Cleared May 14, 2013
ILIZAROV DRILL TIP WIRES
K130479
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared May 03, 2013
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)
K130334
Stryker Trauma AG
Orthopedic · 81d
Cleared Apr 19, 2013
NEWFIX EXTERNAL FIXATION SYSTEM
K122210
Tecnologia Y Diseno Industrial, S.A DE C.V
Orthopedic · 268d
Cleared Apr 11, 2013
SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM
K122455
Synthes
Orthopedic · 241d
Cleared Apr 05, 2013
SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM
K130044
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Oct 24, 2012
HOFFMANN 3
K122284
Stryker Corp.
Orthopedic · 86d
Cleared Sep 04, 2012
ORTHOFIX GALAXY FIXATION SYSTEM
K113770
Orthofix Srl
Orthopedic · 257d
Cleared Jul 25, 2012
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
K121252
Stryker Corp.
Orthopedic · 91d
Cleared Jun 26, 2012
XTRAFIX EXTERNAL FIXATION SYSTEM
K113383
Extraortho, Inc.
Orthopedic · 223d