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 Synthes (Usa), Howmedica Corp. and Howmedica Osteonics Corp..

403
Total
403
Cleared
107d
Avg days
1979
Since
403 devices
97–120 of 403
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 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 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 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
Cleared Sep 24, 2004
HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K042019
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Sep 24, 2004
JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE
K042312
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 08, 2004
HOFFMANN II FOOT RING
K041706
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared Sep 08, 2004
NUMELOCK II SYSTEM
K041709
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared Sep 08, 2004
SYNTHES (USA) LCP CURVED PLATES
K041911
Synthes (Usa)
Orthopedic · 55d
Cleared Jul 01, 2004
OMEGA 2 SYSTEM
K041001
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared Mar 23, 2004
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
K040258
Synthes (Usa)
Orthopedic · 48d
Cleared Mar 01, 2004
3.5 MM LCP DISTAL HUMERUS SYSTEM
K033995
Synthes (Usa)
Orthopedic · 68d
Cleared Jan 20, 2004
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K033476
Howmedica Osteonics Corp.
Orthopedic · 78d
Cleared Jan 13, 2004
SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
K033556
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
K033411
Synthes (Usa)
Orthopedic · 30d
Cleared Nov 05, 2003
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
K033158
Synthes (Usa)
Orthopedic · 36d