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
Sep 27, 2010
SMITH & NEPHEW CIRCULAR FIXATION SYSTEM
Smith & Nephew, Inc.
Orthopedic
362d
Cleared
Sep 02, 2010
JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING
Smith & Nephew, Inc.
Orthopedic
164d
Cleared
Jun 10, 2010
SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES
Wrightmedicaltechnologyinc
Orthopedic
142d
Cleared
May 11, 2010
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
Synthes (Usa)
Orthopedic
294d
Cleared
Mar 03, 2010
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
Synthes (Usa)
Orthopedic
356d
Cleared
Dec 10, 2009
AFGHAN EXTERNAL FIXATOR
Smith & Nephew, Inc.
Orthopedic
161d
Cleared
Dec 01, 2009
BIOMET VISION FOOTRING SYSTEM
Ebi, L.P.
Orthopedic
62d
Cleared
Oct 08, 2009
HOFFMAN XPRESS LINE EXTENSION
Howmedica Osteonics Corp.
Orthopedic
23d
Cleared
Jun 08, 2009
SMITH & NEPHEW RAIL SYSTEM
Smith & Nephew, Inc.
Orthopedic
67d
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
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
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
Apr 12, 2007
OMEGA 3 SUPRACONDYLAR PLATE
Howmedica Osteonics Corp.
Orthopedic
55d
Cleared
Jan 04, 2007
DEPUY PEAK FX HIP PLATE
DePuy Orthopaedics, Inc.
Orthopedic
45d