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
Feb 21, 2017
Arrowhead Mini-Rail Fixator
Arrowhead De, LLC
Orthopedic
214d
Cleared
Dec 28, 2016
Gexfix External Fixation
Gexfix International Corp.
Orthopedic
266d
Cleared
Nov 15, 2016
Hoffman LRF System
Stryker GmbH
Orthopedic
144d
Cleared
Nov 10, 2016
DePuy Synthes MAXFRAME Multi-Axial Correction System
Synthes (Usa), LLC
Orthopedic
171d
Cleared
Jul 06, 2016
Integra External Fixation System
Ascension Orthopedics
Orthopedic
103d
Cleared
Apr 11, 2016
Hoffmann LRF (Limb Reconstruction Frame) System
Stryker GmbH
Orthopedic
140d
Cleared
Mar 24, 2016
X-Fix Line Additions
Vilex IN Tennessee, Inc.
Orthopedic
259d
Cleared
Feb 16, 2016
D.N.E. External Fixation System
Dne, LLC
Orthopedic
250d
Cleared
Jan 13, 2016
Reprocessed Stryker External Fixation Devices
Stryker Sustainability Solutions
Orthopedic
49d
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
Cleared
Dec 01, 2015
RX-FIX Mini Rail External Fixator
Wrightmedicaltechnologyinc
Orthopedic
265d
Cleared
Nov 02, 2015
FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control
Zimmer, Inc.
Orthopedic
105d
Cleared
Sep 28, 2015
ARIX Ankle System
Jeil Medical Corporation
Orthopedic
56d
Cleared
Sep 28, 2015
Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4
Orthofix Srl
Orthopedic
55d
Cleared
Aug 21, 2015
SALVATION® External Fixation System
Wrightmedicaltechnologyinc
Orthopedic
29d
Cleared
May 01, 2015
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System
Zimmer, Inc.
Orthopedic
35d
Cleared
Apr 29, 2015
Cardinal Health External Fixation System
Cardinalhealth
Orthopedic
51d
Cleared
Mar 04, 2015
SALVATION External Fixation System
Wrightmedicaltechnologyinc
Orthopedic
61d
Cleared
Jan 08, 2015
SIDEKICK EZ FRAME External Fixation System
Wrightmedicaltechnologyinc
Orthopedic
59d
Cleared
Dec 10, 2014
Orthofix True Lok Hexapod System VI.3
Orthofix Srl
Orthopedic
40d