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..

405
Total
405
Cleared
107d
Avg days
1979
Since
405 devices
145–168 of 405
Cleared May 27, 2010
FUSION MEDICAL RING LOCK SYSTEM
K100857
John J Riccio
Orthopedic · 62d
Cleared May 11, 2010
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
K092190
Synthes (Usa)
Orthopedic · 294d
Cleared Mar 03, 2010
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
K090658
Synthes (Usa)
Orthopedic · 356d
Cleared Jan 07, 2010
MINI RAIL EXTERNAL FIXATOR SYSTEM
K093550
Small Bone Innovations, Inc.
Orthopedic · 51d
Cleared Dec 10, 2009
AFGHAN EXTERNAL FIXATOR
K092002
Smith & Nephew, Inc.
Orthopedic · 161d
Cleared Dec 01, 2009
BIOMET VISION FOOTRING SYSTEM
K093057
Ebi, L.P.
Orthopedic · 62d
Cleared Oct 08, 2009
HOFFMAN XPRESS LINE EXTENSION
K092834
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Sep 08, 2009
ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW)
K091619
Anglefix
Orthopedic · 97d
Cleared Aug 26, 2009
SIGN HIP CONSTRUCT (SHC), MODEL: 701
K083582
Surgical Implant Generation Network (Sign)
Orthopedic · 265d
Cleared Jul 24, 2009
EXTRAFIX EXTERNAL FIXATION SYSTEM
K091258
Qfx Technologies, Inc.
Orthopedic · 86d
Cleared Jun 08, 2009
SMITH & NEPHEW RAIL SYSTEM
K090926
Smith & Nephew, Inc.
Orthopedic · 67d
Cleared Apr 22, 2009
MERETE LOCKING BONE PLATE SYSTEM
K090063
Merete Medical, Inc.
Orthopedic · 103d
Cleared Mar 23, 2009
ACE FISCHER EXTERNAL FIXATION SYSTEM
K083789
DePuy Orthopaedics, Inc.
Orthopedic · 94d
Cleared Mar 02, 2009
REPROCESSED EXTERNAL FIXATION DEVICE
K083636
Sterilmed, Inc.
Orthopedic · 83d
Cleared Feb 05, 2009
NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
K082833
Nutek Orthopaedics, Inc.
Orthopedic · 132d
Cleared Nov 18, 2008
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
K082650
Synthes (Usa)
Orthopedic · 67d
Cleared Aug 18, 2008
REPROCESSED EXTERNAL FIXATION DEVICE
K081586
Sterilmed, Inc.
Orthopedic · 74d
Cleared Aug 13, 2008
REPROCESSED EXTERNAL FIXATION ACCESSORIES
K081342
Sterilmed, Inc.
Orthopedic · 92d
Cleared Jul 30, 2008
LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS
K081244
Biomet Trauma
Orthopedic · 90d
Cleared Jul 18, 2008
VARIAX DISTAL FIBULA PLATE
K081284
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared May 29, 2008
OMEGA 3 TROCHANTERIC STABILIZING PLATE
K081278
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Apr 25, 2008
EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD
K080408
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 71d
Cleared Mar 07, 2008
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
K072212
Smith & Nephew, Inc.
Orthopedic · 211d
Cleared Feb 15, 2008
HOFFMANN LIGHT SYSTEM
K073076
Howmedica Osteonics Corp.
Orthopedic · 107d