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