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 Synthes (Usa), Howmedica Corp. and Howmedica Osteonics Corp..
403
Total
403
Cleared
107d
Avg days
1979
Since
403 devices
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
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
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 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
Cleared
Sep 24, 2004
HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
Howmedica Osteonics Corp.
Orthopedic
59d
Cleared
Sep 24, 2004
JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE
Smith & Nephew, Inc.
Orthopedic
29d
Cleared
Sep 08, 2004
HOFFMANN II FOOT RING
Howmedica Osteonics Corp.
Orthopedic
77d
Cleared
Sep 08, 2004
NUMELOCK II SYSTEM
Howmedica Osteonics Corp.
Orthopedic
77d
Cleared
Sep 08, 2004
SYNTHES (USA) LCP CURVED PLATES
Synthes (Usa)
Orthopedic
55d
Cleared
Jul 01, 2004
OMEGA 2 SYSTEM
Howmedica Osteonics Corp.
Orthopedic
73d
Cleared
Mar 23, 2004
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
Synthes (Usa)
Orthopedic
48d
Cleared
Mar 01, 2004
3.5 MM LCP DISTAL HUMERUS SYSTEM
Synthes (Usa)
Orthopedic
68d
Cleared
Jan 20, 2004
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
Howmedica Osteonics Corp.
Orthopedic
78d
Cleared
Jan 13, 2004
SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
Synthes (Usa)
Orthopedic
62d
Cleared
Nov 26, 2003
SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS
Synthes (Usa)
Orthopedic
30d
Cleared
Nov 05, 2003
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
Synthes (Usa)
Orthopedic
36d