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
73–96 of 403
Cleared Sep 18, 2014
XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K141697
Zimmer, Inc.
Orthopedic · 86d
Cleared Jan 28, 2014
XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K131413
Zimmer, Inc.
Orthopedic · 257d
Cleared May 14, 2013
ILIZAROV DRILL TIP WIRES
K130479
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Apr 05, 2013
SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM
K130044
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Feb 08, 2011
SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE
K110069
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 27, 2010
SMITH & NEPHEW CIRCULAR FIXATION SYSTEM
K093047
Smith & Nephew, Inc.
Orthopedic · 362d
Cleared Sep 02, 2010
JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING
K100795
Smith & Nephew, Inc.
Orthopedic · 164d
Cleared Jun 10, 2010
SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES
K100137
Wrightmedicaltechnologyinc
Orthopedic · 142d
Cleared May 11, 2010
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
K092190
Synthes (Usa)
Orthopedic · 294d
Cleared Mar 03, 2010
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
K090658
Synthes (Usa)
Orthopedic · 356d
Cleared Dec 10, 2009
AFGHAN EXTERNAL FIXATOR
K092002
Smith & Nephew, Inc.
Orthopedic · 161d
Cleared Oct 08, 2009
HOFFMAN XPRESS LINE EXTENSION
K092834
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Jun 08, 2009
SMITH & NEPHEW RAIL SYSTEM
K090926
Smith & Nephew, Inc.
Orthopedic · 67d
Cleared Nov 18, 2008
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
K082650
Synthes (Usa)
Orthopedic · 67d
Cleared Jul 18, 2008
VARIAX DISTAL FIBULA PLATE
K081284
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared May 29, 2008
OMEGA 3 TROCHANTERIC STABILIZING PLATE
K081278
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Mar 07, 2008
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
K072212
Smith & Nephew, Inc.
Orthopedic · 211d
Cleared Feb 15, 2008
HOFFMANN LIGHT SYSTEM
K073076
Howmedica Osteonics Corp.
Orthopedic · 107d
Cleared Feb 14, 2008
VARIAX ELBOW SYSTEM
K073527
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Feb 07, 2008
SIDEKICK RAIL FIXATOR
K080071
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Apr 12, 2007
OMEGA 3 SUPRACONDYLAR PLATE
K070454
Howmedica Osteonics Corp.
Orthopedic · 55d
Cleared Aug 15, 2006
OMEGA 3 SYSTEM
K062066
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Apr 21, 2006
VARIAX LOCKING PLATE SYSTEM
K060613
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Jan 11, 2006
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K053472
Howmedica Osteonics Corp.
Orthopedic · 28d