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
Cleared
Dec 08, 2014
ORTHOFIX GALAXY WRIST
Orthofix Srl
Orthopedic
160d
Cleared
Dec 05, 2014
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT
Orthofix Srl
Orthopedic
130d
Cleared
Nov 20, 2014
Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software
Smith & Nephew, Inc.
Orthopedic
73d
Cleared
Nov 10, 2014
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
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
Advanced Orthopaedic Solutions, Inc.
Orthopedic
106d
Cleared
Oct 10, 2014
INTEGRA EXTERNAL FIXATION SYSTEM
Ascension Orthopedic
Orthopedic
228d
Cleared
Sep 18, 2014
XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
Zimmer, Inc.
Orthopedic
86d
Cleared
Sep 02, 2014
ORTHOFIX TL-HEX TRUE LOK HEXALOBE SYSTEM (TL-HEX)
Orthofix Srl
Orthopedic
130d
Cleared
Jun 10, 2014
EMERGE EXTERNAL FIXATION SYSTEM
Emerge Medical, Inc.
Orthopedic
84d
Cleared
May 29, 2014
S.E.A.L. FRACTURE FUSION TUBE
Dne, LLC
Orthopedic
127d
Cleared
May 29, 2014
DRIVE RAIL SYSTEM
Devise Ortho, Inc.
Orthopedic
58d
Cleared
Jan 28, 2014
XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
Zimmer, Inc.
Orthopedic
257d
Cleared
Jan 16, 2014
DOLPHIX EXTERNAL FIXATION SYSTEM
Citieffe S.R.L.
Orthopedic
170d
Cleared
Jun 10, 2013
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
Stryker Trauma AG
Orthopedic
70d
Cleared
May 15, 2013
NBX - NON BRIDGING EXTERNAL FIXATOR HAND
Nutek Orthopaedics, Inc.
Orthopedic
246d
Cleared
May 14, 2013
ILIZAROV DRILL TIP WIRES
Smith & Nephew, Inc.
Orthopedic
78d
Cleared
May 03, 2013
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME SYSTEM)
Stryker Trauma AG
Orthopedic
81d
Cleared
Apr 19, 2013
NEWFIX EXTERNAL FIXATION SYSTEM
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
Synthes
Orthopedic
241d
Cleared
Apr 05, 2013
SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
87d
Cleared
Oct 24, 2012
HOFFMANN 3
Stryker Corp.
Orthopedic
86d
Cleared
Sep 04, 2012
ORTHOFIX GALAXY FIXATION SYSTEM
Orthofix Srl
Orthopedic
257d
Cleared
Jul 25, 2012
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
Stryker Corp.
Orthopedic
91d
Cleared
Jun 26, 2012
XTRAFIX EXTERNAL FIXATION SYSTEM
Extraortho, Inc.
Orthopedic
223d