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
121–144 of 404
Cleared Dec 22, 2006
AEQUALIS HUMERAL PLATE
K063551
Tornier
Orthopedic · 28d
Cleared Aug 15, 2006
OMEGA 3 SYSTEM
K062066
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Apr 21, 2006
UNITY HUMERAL PLATE
K060545
Tornier
Orthopedic · 51d
Cleared Apr 21, 2006
VARIAX LOCKING PLATE SYSTEM
K060613
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Jan 27, 2006
REPROCESSED EXTERNAL FIXATION DEVICES
K052918
Alliance Medical Corp.
Orthopedic · 102d
Cleared Jan 11, 2006
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K053472
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Dec 09, 2005
HOFFMANN II ROD TO WIRE COUPLING
K053349
Howmedica Osteonics Corp.
Orthopedic · 7d
Cleared Nov 22, 2005
HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM
K053038
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Sep 21, 2005
EBI DYNAFIX VISION FOOTPLATE SYSTEM
K052239
Ebi, L.P.
Orthopedic · 35d
Cleared Aug 25, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K052062
Alliance Medical Corp.
Orthopedic · 27d
Cleared Aug 25, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K052064
Alliance Medical Corp.
Orthopedic · 27d
Cleared Aug 22, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K052065
Alliance Medical Corp.
Orthopedic · 24d
Cleared Aug 05, 2005
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K052037
Howmedica Osteonics Corp.
Orthopedic · 8d
Cleared Jul 27, 2005
SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM
K051600
Synthes (Usa)
Orthopedic · 41d
Cleared Jul 13, 2005
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR
K051049
Synthes (Usa)
Orthopedic · 79d
Cleared Jun 29, 2005
ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
K051554
Alliance Medical Corp.
Orthopedic · 16d
Cleared May 04, 2005
HA COATED LAG SCREW
K050849
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Mar 04, 2005
HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM
K050048
Howmedica Osteonics Corp.
Orthopedic · 53d
Cleared Jan 21, 2005
TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
K043113
DePuy Orthopaedics, Inc.
Orthopedic · 72d
Cleared Jan 18, 2005
SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE
K043039
Synthes (Usa)
Orthopedic · 75d
Cleared Nov 17, 2004
WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES
K042761
Zimmer, Inc.
Orthopedic · 43d
Cleared Nov 16, 2004
SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES
K042895
Synthes (Usa)
Orthopedic · 27d
Cleared Oct 07, 2004
LOCON VLS DISTAL RADIUS PLATE SYSTEM
K042358
Wrightmedicaltechnologyinc
Orthopedic · 37d
Cleared Oct 07, 2004
IIIZAROV PULLEY SYSTEM
K042436
Smith & Nephew, Inc.
Orthopedic · 29d