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
49–72 of 404
Cleared Nov 07, 2019
PRECICE Plating System
K192181
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 87d
Cleared Oct 16, 2019
Pitkar External Fixation System
K190486
S.H.Pitkar Orthotools Pvt. , Ltd.
Orthopedic · 230d
Cleared Aug 14, 2019
AutoStrut
K191241
Orthospin
Orthopedic · 98d
Cleared May 29, 2019
Revolution External Plating System
K181630
New Standard Device Dba Metalogix
Orthopedic · 343d
Cleared May 14, 2019
SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
K190069
Arrowhead De, LLC
Orthopedic · 119d
Cleared Apr 08, 2019
OIC External Fixation System
K183682
Orthopaedic Implant Company
Orthopedic · 101d
Cleared Feb 28, 2019
Austin Miller Large External Fixation System
K181528
Austin Miller Trauma, LLC
Orthopedic · 262d
Cleared Jan 25, 2019
Hoffmann LRF System
K182968
Stryker GmbH
Orthopedic · 91d
Cleared Oct 16, 2018
Depuy Synthes Femoral Neck System
K182154
Synthes USA Products, LLC
Orthopedic · 68d
Cleared Sep 07, 2018
External Fixation System
K173883
Life Spine, Inc.
Orthopedic · 260d
Cleared Jul 27, 2018
Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices
K180580
Surgical Instrument Service and Savings, Inc.
Orthopedic · 144d
Cleared Jun 06, 2018
SALVATION External Fixation System
K180832
Wrightmedicaltechnologyinc
Orthopedic · 68d
Cleared Mar 05, 2018
DePuy Synthes Femoral Neck System
K172872
DePuy Synthes
Orthopedic · 165d
Cleared Jan 12, 2018
ARBOR External Fixation System
K172438
Globus Medical, Inc.
Orthopedic · 154d
Cleared Oct 12, 2017
Galaxy UNYCO System
K170146
Orthofix Srl
Orthopedic · 268d
Cleared May 10, 2017
Orthofix TrueLok Hexapod System (TL-HEX) V2.0
K170650
Orthofix Srl
Orthopedic · 68d
Cleared Apr 14, 2017
Hoffmann LRF System
K163656
Stryker GmbH
Orthopedic · 112d
Cleared Nov 15, 2016
Hoffman LRF System
K161753
Stryker GmbH
Orthopedic · 144d
Cleared Apr 11, 2016
Hoffmann LRF (Limb Reconstruction Frame) System
K153377
Stryker GmbH
Orthopedic · 140d
Cleared Jan 13, 2016
SALVATION(R) External Fixation System
K153635
Wrightmedicaltechnologyinc
Orthopedic · 26d
Cleared Jan 06, 2016
Galaxy UNYCO System
K153233
Orthofix Srl
Orthopedic · 58d
Cleared Dec 30, 2015
Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables
K151907
Zimmer, Inc.
Orthopedic · 170d
Cleared Dec 21, 2015
FastFrame External Fixation System-Ankle Spanning
K152755
Zimmer, Inc.
Orthopedic · 88d
Cleared Dec 04, 2015
FastFrame External Fixation System - Distal Radius
K152484
Zimmer, Inc.
Orthopedic · 95d