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
121–144 of 403
Cleared Jul 14, 2003
EXTERNAL FIXATION SYSTEMS
K031181
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jul 14, 2003
SYNTHES SMALL COBINATION CLAMP-MR SAFE
K031724
Synthes (Usa)
Orthopedic · 41d
Cleared Jun 24, 2003
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
K031725
Synthes (Usa)
Orthopedic · 21d
Cleared Jun 06, 2003
SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE
K031573
Synthes (Usa)
Orthopedic · 17d
Cleared Jan 23, 2003
SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K023941
Synthes (Usa)
Orthopedic · 58d
Cleared Jun 05, 2002
OMEGA II SYSTEM
K020772
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Jun 27, 2001
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
K011034
Synthes (Usa)
Orthopedic · 83d
Cleared Jun 12, 2001
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
K010766
Synthes (Usa)
Orthopedic · 90d
Cleared May 23, 2001
SYNTHES ANTEROLATERAL CALCANEAL PLATE
K010518
Synthes (Usa)
Orthopedic · 90d
Cleared May 03, 2001
ADJUSTABLE LARGE FIXATOR SYSTEM
K010344
Synthes (Usa)
Orthopedic · 87d
Cleared May 01, 2000
SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000682
Synthes (Usa)
Orthopedic · 62d
Cleared Apr 28, 2000
SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000684
Synthes (Usa)
Orthopedic · 59d
Cleared Dec 20, 1999
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
K993289
Smith & Nephew, Inc.
Orthopedic · 80d
Cleared Feb 18, 1999
SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM
K984498
Synthes (Usa)
Orthopedic · 63d
Cleared Apr 14, 1998
BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR
K980370
Biomet, Inc.
Orthopedic · 74d
Cleared Feb 18, 1998
SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM
K974537
Synthes (Usa)
Orthopedic · 77d
Cleared Oct 16, 1997
SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
K973017
Synthes (Usa)
Orthopedic · 64d
Cleared Oct 09, 1997
DEPUY AE TK2 HIP SCREW SYSTEM
K972629
Depuy, Inc.
Orthopedic · 87d
Cleared Jan 22, 1997
MEDOFF SLIDING PLATE (PROPOSED NAME)
K962251
Wrightmedicaltechnologyinc
Orthopedic · 224d
Cleared Sep 05, 1996
SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)
K962484
Synthes (Usa)
Orthopedic · 71d
Cleared Jun 28, 1996
SYNTHES MINI EXTERNAL FIXATOR
K961350
Synthes (Usa)
Orthopedic · 84d
Cleared Jun 13, 1996
ALTA DOME AND PLUNGER (MEC HIP BOLT)
K961213
Howmedica Corp.
Orthopedic · 77d
Cleared Apr 10, 1996
OMEGA+ COMPRESSION SCREW SYSTEM
K955306
Howmedica Corp.
Orthopedic · 142d
Cleared Jan 26, 1996
VERSA-FX FEMORAL FIXATION SYSTEM
K954555
Zimmer, Inc.
Orthopedic · 116d