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
Jul 14, 2003
EXTERNAL FIXATION SYSTEMS
Smith & Nephew, Inc.
Orthopedic
90d
Cleared
Jul 14, 2003
SYNTHES SMALL COBINATION CLAMP-MR SAFE
Synthes (Usa)
Orthopedic
41d
Cleared
Jun 24, 2003
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
Synthes (Usa)
Orthopedic
21d
Cleared
Jun 06, 2003
SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE
Synthes (Usa)
Orthopedic
17d
Cleared
Jan 23, 2003
SYNTHES TOMOFIX OSTEOTOMY SYSTEM
Synthes (Usa)
Orthopedic
58d
Cleared
Jun 05, 2002
OMEGA II SYSTEM
Howmedica Osteonics Corp.
Orthopedic
89d
Cleared
Jun 27, 2001
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
Synthes (Usa)
Orthopedic
83d
Cleared
Jun 12, 2001
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
Synthes (Usa)
Orthopedic
90d
Cleared
May 23, 2001
SYNTHES ANTEROLATERAL CALCANEAL PLATE
Synthes (Usa)
Orthopedic
90d
Cleared
May 03, 2001
ADJUSTABLE LARGE FIXATOR SYSTEM
Synthes (Usa)
Orthopedic
87d
Cleared
May 01, 2000
SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
Synthes (Usa)
Orthopedic
62d
Cleared
Apr 28, 2000
SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
Synthes (Usa)
Orthopedic
59d
Cleared
Dec 20, 1999
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
Smith & Nephew, Inc.
Orthopedic
80d
Cleared
Feb 18, 1999
SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM
Synthes (Usa)
Orthopedic
63d
Cleared
Apr 14, 1998
BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR
Biomet, Inc.
Orthopedic
74d
Cleared
Feb 18, 1998
SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM
Synthes (Usa)
Orthopedic
77d
Cleared
Oct 16, 1997
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
Synthes (Usa)
Orthopedic
64d
Cleared
Oct 09, 1997
DEPUY AE TK2 HIP SCREW SYSTEM
Depuy, Inc.
Orthopedic
87d
Cleared
Jan 22, 1997
MEDOFF SLIDING PLATE (PROPOSED NAME)
Wrightmedicaltechnologyinc
Orthopedic
224d
Cleared
Sep 05, 1996
SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)
Synthes (Usa)
Orthopedic
71d
Cleared
Jun 28, 1996
SYNTHES MINI EXTERNAL FIXATOR
Synthes (Usa)
Orthopedic
84d
Cleared
Jun 13, 1996
ALTA DOME AND PLUNGER (MEC HIP BOLT)
Howmedica Corp.
Orthopedic
77d
Cleared
Apr 10, 1996
OMEGA+ COMPRESSION SCREW SYSTEM
Howmedica Corp.
Orthopedic
142d
Cleared
Jan 26, 1996
VERSA-FX FEMORAL FIXATION SYSTEM
Zimmer, Inc.
Orthopedic
116d