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 Synthes (Usa), Howmedica Corp. and Howmedica Osteonics Corp..

403
Total
403
Cleared
107d
Avg days
1979
Since
403 devices
25–48 of 403
Cleared Feb 10, 2023
Orthex External Fixation System
K223786
OrthoPediatrics Corp.
Orthopedic · 53d
Cleared Aug 25, 2022
ONX Large External Fixation System
K213905
Orthonovis, Inc.
Orthopedic · 254d
Cleared Jun 06, 2022
Smart Correction System Rings and Compatible HA-Coated Half Pins
K221366
Wishbone Medical, Inc.
Orthopedic · 25d
Cleared Apr 08, 2022
Drive Rail System
K220809
OrthoPediatrics Corp.
Orthopedic · 18d
Cleared Nov 08, 2021
Paragon 28 External Ring Fixation System
K212895
Paragon 28, Inc.
Orthopedic · 59d
Cleared Nov 05, 2021
TrueLok Evo
K212044
Orthofix Srl
Orthopedic · 128d
Cleared Oct 12, 2021
Correx Software
K212552
Vilex, LLC
Orthopedic · 60d
Cleared Jul 29, 2021
SMART Taylor Spatial Frame
K210953
Smith & Nephew, Inc.
Orthopedic · 121d
Cleared May 25, 2021
MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
K211313
Synthes USA Products, LLC
Orthopedic · 25d
Cleared May 05, 2021
OIC External Fixation System
K211112
Orthopaedic Implant Company
Orthopedic · 21d
Cleared Feb 01, 2021
Hoffmann LRF System
K203568
Stryker GmbH
Orthopedic · 56d
Cleared Jan 19, 2021
Sequel External Fixation Device
K202833
Sequel Medical, Inc.
Orthopedic · 116d
Cleared Jan 06, 2021
AutoStrut G2
K202810
Orthospin, Ltd.
Orthopedic · 105d
Cleared Jan 05, 2021
Bfix Orthopedic External Fixator Systems
K200491
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
K201253
Smith & Nephew
Orthopedic · 211d
Cleared Nov 16, 2020
Circular Fixation with Balanced Cable Transport
K202762
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Oct 06, 2020
Pitkar DeftFix System
K200728
S.H.Pitkar Orthotools Pvt. , Ltd.
Orthopedic · 200d
Cleared Sep 22, 2020
Accessories for the SixFix® Hexapod Fixator
K200123
Arrowhead De, LLC
Orthopedic · 245d
Cleared Sep 18, 2020
Smart Correction System
K193368
Wishbone Medical, Inc.
Orthopedic · 288d
Cleared Sep 14, 2020
FusionFrame Ring Lock System
K200343
Glw Medical Innovation
Orthopedic · 216d
Cleared Sep 11, 2020
Dynex Micro
K202143
Vilex, LLC
Orthopedic · 42d
Cleared Aug 24, 2020
Dynex Ring Fixation System, Diametrix Ring Fixation System
K202054
Vilex, LLC
Orthopedic · 31d
Cleared Jul 29, 2020
Pitkar External Fixation System - Rail Mechanism
K200518
S.H.Pitkar Orthotools Pvt. , Ltd.
Orthopedic · 149d
Cleared Nov 07, 2019
PRECICE Plating System
K192181
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 87d