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
145–168 of 404
Cleared Mar 23, 2009
ACE FISCHER EXTERNAL FIXATION SYSTEM
K083789
DePuy Orthopaedics, Inc.
Orthopedic · 94d
Cleared Mar 02, 2009
REPROCESSED EXTERNAL FIXATION DEVICE
K083636
Sterilmed, Inc.
Orthopedic · 83d
Cleared Nov 18, 2008
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
K082650
Synthes (Usa)
Orthopedic · 67d
Cleared Aug 18, 2008
REPROCESSED EXTERNAL FIXATION DEVICE
K081586
Sterilmed, Inc.
Orthopedic · 74d
Cleared Aug 13, 2008
REPROCESSED EXTERNAL FIXATION ACCESSORIES
K081342
Sterilmed, Inc.
Orthopedic · 92d
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 Apr 25, 2008
EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD
K080408
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 71d
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 Nov 09, 2007
SUPERCABLE GRIP AND PLATE SYSTEM
K072250
Kinamed, Inc.
Orthopedic · 88d
Cleared Aug 29, 2007
AAP APS SYSTEM
K071852
Aap Implantate AG
Orthopedic · 55d
Cleared Jul 09, 2007
BIOMET VISION FOOTRING SYSTEM
K071395
Biomet Manufacturing Corp
Orthopedic · 49d
Cleared Jun 29, 2007
MODIFICATION TO:SBI RINGFIX
K071394
Small Bone Innovations, Inc.
Orthopedic · 39d
Cleared Apr 12, 2007
OMEGA 3 SUPRACONDYLAR PLATE
K070454
Howmedica Osteonics Corp.
Orthopedic · 55d
Cleared Jan 22, 2007
MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE
K063487
Merete Medical GmbH
Orthopedic · 66d
Cleared Jan 04, 2007
DEPUY PEAK FX HIP PLATE
K063509
DePuy Orthopaedics, Inc.
Orthopedic · 45d
Cleared Dec 22, 2006
AEQUALIS HUMERAL PLATE
K063551
Tornier
Orthopedic · 28d
Cleared Sep 05, 2006
REPROCESSED EXTERNAL FIXATION DEVICE
K061759
Ascent Healthcare Solutions
Orthopedic · 75d
Cleared Aug 15, 2006
OMEGA 3 SYSTEM
K062066
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Apr 21, 2006
UNITY HUMERAL PLATE
K060545
Tornier
Orthopedic · 51d
Cleared Apr 21, 2006
VARIAX LOCKING PLATE SYSTEM
K060613
Howmedica Osteonics Corp.
Orthopedic · 45d