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 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 Dec 01, 2009
BIOMET VISION FOOTRING SYSTEM
K093057
Ebi, L.P.
Orthopedic · 62d
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 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 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 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 Apr 12, 2007
OMEGA 3 SUPRACONDYLAR PLATE
K070454
Howmedica Osteonics Corp.
Orthopedic · 55d
Cleared Jan 04, 2007
DEPUY PEAK FX HIP PLATE
K063509
DePuy Orthopaedics, Inc.
Orthopedic · 45d