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
Mar 23, 2009
ACE FISCHER EXTERNAL FIXATION SYSTEM
DePuy Orthopaedics, Inc.
Orthopedic
94d
Cleared
Mar 02, 2009
REPROCESSED EXTERNAL FIXATION DEVICE
Sterilmed, Inc.
Orthopedic
83d
Cleared
Nov 18, 2008
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
Synthes (Usa)
Orthopedic
67d
Cleared
Aug 18, 2008
REPROCESSED EXTERNAL FIXATION DEVICE
Sterilmed, Inc.
Orthopedic
74d
Cleared
Aug 13, 2008
REPROCESSED EXTERNAL FIXATION ACCESSORIES
Sterilmed, Inc.
Orthopedic
92d
Cleared
Jul 18, 2008
VARIAX DISTAL FIBULA PLATE
Howmedica Osteonics Corp.
Orthopedic
73d
Cleared
May 29, 2008
OMEGA 3 TROCHANTERIC STABILIZING PLATE
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
Advanced Orthopaedic Solutions, Inc.
Orthopedic
71d
Cleared
Mar 07, 2008
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
Smith & Nephew, Inc.
Orthopedic
211d
Cleared
Feb 15, 2008
HOFFMANN LIGHT SYSTEM
Howmedica Osteonics Corp.
Orthopedic
107d
Cleared
Feb 14, 2008
VARIAX ELBOW SYSTEM
Howmedica Osteonics Corp.
Orthopedic
59d
Cleared
Feb 07, 2008
SIDEKICK RAIL FIXATOR
Wrightmedicaltechnologyinc
Orthopedic
27d
Cleared
Nov 09, 2007
SUPERCABLE GRIP AND PLATE SYSTEM
Kinamed, Inc.
Orthopedic
88d
Cleared
Aug 29, 2007
AAP APS SYSTEM
Aap Implantate AG
Orthopedic
55d
Cleared
Jul 09, 2007
BIOMET VISION FOOTRING SYSTEM
Biomet Manufacturing Corp
Orthopedic
49d
Cleared
Jun 29, 2007
MODIFICATION TO:SBI RINGFIX
Small Bone Innovations, Inc.
Orthopedic
39d
Cleared
Apr 12, 2007
OMEGA 3 SUPRACONDYLAR PLATE
Howmedica Osteonics Corp.
Orthopedic
55d
Cleared
Jan 22, 2007
MERETE BLP SMALL FRAGMENT LOCKING BONE PLATE
Merete Medical GmbH
Orthopedic
66d
Cleared
Jan 04, 2007
DEPUY PEAK FX HIP PLATE
DePuy Orthopaedics, Inc.
Orthopedic
45d
Cleared
Dec 22, 2006
AEQUALIS HUMERAL PLATE
Tornier
Orthopedic
28d
Cleared
Sep 05, 2006
REPROCESSED EXTERNAL FIXATION DEVICE
Ascent Healthcare Solutions
Orthopedic
75d
Cleared
Aug 15, 2006
OMEGA 3 SYSTEM
Howmedica Osteonics Corp.
Orthopedic
25d
Cleared
Apr 21, 2006
UNITY HUMERAL PLATE
Tornier
Orthopedic
51d
Cleared
Apr 21, 2006
VARIAX LOCKING PLATE SYSTEM
Howmedica Osteonics Corp.
Orthopedic
45d