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..

405
Total
405
Cleared
107d
Avg days
1979
Since
405 devices
121–144 of 405
Cleared Jun 26, 2012
XTRAFIX EXTERNAL FIXATION SYSTEM
K113383
Extraortho, Inc.
Orthopedic · 223d
Cleared May 01, 2012
EXTERNAL FIXATOR ST.A R 90 F4
K113384
Citieffe
Orthopedic · 167d
Cleared Mar 29, 2012
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K113327
Stryker Corp.
Orthopedic · 140d
Cleared Jan 26, 2012
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM
K111786
Stryker Corp.
Orthopedic · 216d
Cleared Jan 12, 2012
OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM
K113123
The Orthopaedic Implant Company
Orthopedic · 83d
Cleared Jan 04, 2012
DNE EXTERNAL FIXATION SYSTEM
K113106
Dne, LLC
Orthopedic · 76d
Cleared Dec 15, 2011
ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS
K112218
DePuy Orthopaedics, Inc.
Orthopedic · 135d
Cleared Nov 02, 2011
DYNA-EXTOR II
K110426
Bk Meditech, Co., Ltd.
Orthopedic · 261d
Cleared Oct 24, 2011
FRAMEWALKER
K111993
Quantum Medical Concepts, LLC
Orthopedic · 103d
Cleared Oct 20, 2011
XTRAFIX EXTERNAL FIXATION SYSTEM
K111155
Extraortho, Inc.
Orthopedic · 178d
Cleared Aug 03, 2011
CONSTRUX EXTERNAL FIXATION DEVICE
K111376
Ebi, LLC
Orthopedic · 79d
Cleared May 11, 2011
RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
K110965
Renovis Surgical Technologies, LLC
Orthopedic · 35d
Cleared May 03, 2011
MAC MALE ADAPTER
K102843
Biomet Trauma (Aka Ebi, LLC)
Orthopedic · 216d
Cleared Apr 13, 2011
ODRC-DYNAMIC HIP SCREW SYSTEM
K103015
Orthopaedic Device Research Center
Orthopedic · 183d
Cleared Mar 14, 2011
NEWFIX EXTERNAL FIXATION SYSTEM
K101338
Technologia Y Diseno Industrial, S.A DE C.V
Orthopedic · 306d
Cleared Feb 08, 2011
SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE
K110069
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Dec 21, 2010
TARGON FN SYSTEM
K102057
Aesculap Implant Systems, LLC
Orthopedic · 152d
Cleared Dec 03, 2010
MERETE LOCKING BONE PLATE SYSTEM II
K102688
Merete Medical GmbH
Orthopedic · 77d
Cleared Oct 22, 2010
QUANTUM RING FIXATION SYSTEM MODEL ISF
K101759
Quantum Medical Concepts, LLC
Orthopedic · 121d
Cleared Sep 27, 2010
SMITH & NEPHEW CIRCULAR FIXATION SYSTEM
K093047
Smith & Nephew, Inc.
Orthopedic · 362d
Cleared Sep 17, 2010
ACUTE INNOVATIONS STERNAL FIXATION SYSTEM
K101170
Acute Innovations, LLC
Orthopedic · 144d
Cleared Sep 02, 2010
JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING
K100795
Smith & Nephew, Inc.
Orthopedic · 164d
Cleared Aug 26, 2010
MDPO FRAME SYSTEM
K093753
Mdpo, LLC
Orthopedic · 262d
Cleared Jun 10, 2010
SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES
K100137
Wrightmedicaltechnologyinc
Orthopedic · 142d