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
Dec 22, 2006
AEQUALIS HUMERAL PLATE
Tornier
Orthopedic
28d
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
Cleared
Jan 27, 2006
REPROCESSED EXTERNAL FIXATION DEVICES
Alliance Medical Corp.
Orthopedic
102d
Cleared
Jan 11, 2006
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
Howmedica Osteonics Corp.
Orthopedic
28d
Cleared
Dec 09, 2005
HOFFMANN II ROD TO WIRE COUPLING
Howmedica Osteonics Corp.
Orthopedic
7d
Cleared
Nov 22, 2005
HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM
Howmedica Osteonics Corp.
Orthopedic
26d
Cleared
Sep 21, 2005
EBI DYNAFIX VISION FOOTPLATE SYSTEM
Ebi, L.P.
Orthopedic
35d
Cleared
Aug 25, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
Alliance Medical Corp.
Orthopedic
27d
Cleared
Aug 25, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
Alliance Medical Corp.
Orthopedic
27d
Cleared
Aug 22, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
Alliance Medical Corp.
Orthopedic
24d
Cleared
Aug 05, 2005
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
Howmedica Osteonics Corp.
Orthopedic
8d
Cleared
Jul 27, 2005
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
Synthes (Usa)
Orthopedic
41d
Cleared
Jul 13, 2005
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR
Synthes (Usa)
Orthopedic
79d
Cleared
Jun 29, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
Alliance Medical Corp.
Orthopedic
16d
Cleared
May 04, 2005
HA COATED LAG SCREW
Smith & Nephew, Inc.
Orthopedic
30d
Cleared
Mar 04, 2005
HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM
Howmedica Osteonics Corp.
Orthopedic
53d
Cleared
Jan 21, 2005
TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
DePuy Orthopaedics, Inc.
Orthopedic
72d
Cleared
Jan 18, 2005
SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE
Synthes (Usa)
Orthopedic
75d
Cleared
Nov 17, 2004
WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES
Zimmer, Inc.
Orthopedic
43d
Cleared
Nov 16, 2004
SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES
Synthes (Usa)
Orthopedic
27d
Cleared
Oct 07, 2004
LOCON VLS DISTAL RADIUS PLATE SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
37d
Cleared
Oct 07, 2004
IIIZAROV PULLEY SYSTEM
Smith & Nephew, Inc.
Orthopedic
29d