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
73–96 of 404
Cleared Feb 21, 2017
Arrowhead Mini-Rail Fixator
K162032
Arrowhead De, LLC
Orthopedic · 214d
Cleared Dec 28, 2016
Gexfix External Fixation
K160972
Gexfix International Corp.
Orthopedic · 266d
Cleared Nov 15, 2016
Hoffman LRF System
K161753
Stryker GmbH
Orthopedic · 144d
Cleared Nov 10, 2016
DePuy Synthes MAXFRAME Multi-Axial Correction System
K161417
Synthes (Usa), LLC
Orthopedic · 171d
Cleared Jul 06, 2016
Integra External Fixation System
K160830
Ascension Orthopedics
Orthopedic · 103d
Cleared Apr 11, 2016
Hoffmann LRF (Limb Reconstruction Frame) System
K153377
Stryker GmbH
Orthopedic · 140d
Cleared Mar 24, 2016
X-Fix Line Additions
K151881
Vilex IN Tennessee, Inc.
Orthopedic · 259d
Cleared Feb 16, 2016
D.N.E. External Fixation System
K151580
Dne, LLC
Orthopedic · 250d
Cleared Jan 13, 2016
Reprocessed Stryker External Fixation Devices
K153415
Stryker Sustainability Solutions
Orthopedic · 49d
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
Cleared Dec 01, 2015
RX-FIX Mini Rail External Fixator
K150640
Wrightmedicaltechnologyinc
Orthopedic · 265d
Cleared Nov 02, 2015
FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control
K151992
Zimmer, Inc.
Orthopedic · 105d
Cleared Sep 28, 2015
ARIX Ankle System
K152158
Jeil Medical Corporation
Orthopedic · 56d
Cleared Sep 28, 2015
Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4
K152171
Orthofix Srl
Orthopedic · 55d
Cleared Aug 21, 2015
SALVATION® External Fixation System
K152045
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared May 01, 2015
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System
K150818
Zimmer, Inc.
Orthopedic · 35d
Cleared Apr 29, 2015
Cardinal Health External Fixation System
K150579
Cardinalhealth
Orthopedic · 51d
Cleared Mar 04, 2015
SALVATION External Fixation System
K150004
Wrightmedicaltechnologyinc
Orthopedic · 61d
Cleared Jan 08, 2015
SIDEKICK EZ FRAME External Fixation System
K143220
Wrightmedicaltechnologyinc
Orthopedic · 59d
Cleared Dec 10, 2014
Orthofix True Lok Hexapod System VI.3
K143125
Orthofix Srl
Orthopedic · 40d