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 Synthes (Usa), Howmedica Corp. and Howmedica Osteonics Corp..
403
Total
403
Cleared
107d
Avg days
1979
Since
403 devices
Cleared
Feb 10, 2023
Orthex External Fixation System
OrthoPediatrics Corp.
Orthopedic
53d
Cleared
Aug 25, 2022
ONX Large External Fixation System
Orthonovis, Inc.
Orthopedic
254d
Cleared
Jun 06, 2022
Smart Correction System Rings and Compatible HA-Coated Half Pins
Wishbone Medical, Inc.
Orthopedic
25d
Cleared
Apr 08, 2022
Drive Rail System
OrthoPediatrics Corp.
Orthopedic
18d
Cleared
Nov 08, 2021
Paragon 28 External Ring Fixation System
Paragon 28, Inc.
Orthopedic
59d
Cleared
Nov 05, 2021
TrueLok Evo
Orthofix Srl
Orthopedic
128d
Cleared
Oct 12, 2021
Correx Software
Vilex, LLC
Orthopedic
60d
Cleared
Jul 29, 2021
SMART Taylor Spatial Frame
Smith & Nephew, Inc.
Orthopedic
121d
Cleared
May 25, 2021
MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
Synthes USA Products, LLC
Orthopedic
25d
Cleared
May 05, 2021
OIC External Fixation System
Orthopaedic Implant Company
Orthopedic
21d
Cleared
Feb 01, 2021
Hoffmann LRF System
Stryker GmbH
Orthopedic
56d
Cleared
Jan 19, 2021
Sequel External Fixation Device
Sequel Medical, Inc.
Orthopedic
116d
Cleared
Jan 06, 2021
AutoStrut G2
Orthospin, Ltd.
Orthopedic
105d
Cleared
Jan 05, 2021
Bfix Orthopedic External Fixator Systems
Aike (Shanghai) Medical Instrument Co., Ltd.
Orthopedic
312d
Cleared
Dec 08, 2020
Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation
Smith & Nephew
Orthopedic
211d
Cleared
Nov 16, 2020
Circular Fixation with Balanced Cable Transport
Smith & Nephew, Inc.
Orthopedic
56d
Cleared
Oct 06, 2020
Pitkar DeftFix System
S.H.Pitkar Orthotools Pvt. , Ltd.
Orthopedic
200d
Cleared
Sep 22, 2020
Accessories for the SixFix® Hexapod Fixator
Arrowhead De, LLC
Orthopedic
245d
Cleared
Sep 18, 2020
Smart Correction System
Wishbone Medical, Inc.
Orthopedic
288d
Cleared
Sep 14, 2020
FusionFrame Ring Lock System
Glw Medical Innovation
Orthopedic
216d
Cleared
Sep 11, 2020
Dynex Micro
Vilex, LLC
Orthopedic
42d
Cleared
Aug 24, 2020
Dynex Ring Fixation System, Diametrix Ring Fixation System
Vilex, LLC
Orthopedic
31d
Cleared
Jul 29, 2020
Pitkar External Fixation System - Rail Mechanism
S.H.Pitkar Orthotools Pvt. , Ltd.
Orthopedic
149d
Cleared
Nov 07, 2019
PRECICE Plating System
Nuvasive Specialized Orthopedics, Inc.
Orthopedic
87d