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
145–168 of 404
Cleared Sep 24, 2004
HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K042019
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Sep 24, 2004
JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE
K042312
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 08, 2004
HOFFMANN II FOOT RING
K041706
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared Sep 08, 2004
NUMELOCK II SYSTEM
K041709
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared Sep 08, 2004
SYNTHES (USA) LCP CURVED PLATES
K041911
Synthes (Usa)
Orthopedic · 55d
Cleared Jul 06, 2004
EBI XFIX DFS SYSTEM
K040935
Ebi, L.P.
Orthopedic · 88d
Cleared Jul 01, 2004
OMEGA 2 SYSTEM
K041001
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared Apr 29, 2004
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K040833
Ebi, L.P.
Orthopedic · 29d
Cleared Mar 23, 2004
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
K040258
Synthes (Usa)
Orthopedic · 48d
Cleared Mar 01, 2004
3.5 MM LCP DISTAL HUMERUS SYSTEM
K033995
Synthes (Usa)
Orthopedic · 68d
Cleared Jan 20, 2004
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K033476
Howmedica Osteonics Corp.
Orthopedic · 78d
Cleared Jan 13, 2004
SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
K033556
Synthes (Usa)
Orthopedic · 62d
Cleared Dec 18, 2003
MODIFICATION TO SLIM GLIDING NAIL SYSTEM
K033763
Plus Orthopedics
Orthopedic · 16d
Cleared Dec 03, 2003
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K033635
Ebi, L.P.
Orthopedic · 14d
Cleared Nov 26, 2003
SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS
K033411
Synthes (Usa)
Orthopedic · 30d
Cleared Nov 05, 2003
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
K033158
Synthes (Usa)
Orthopedic · 36d
Cleared Sep 04, 2003
EBI XFIX DFS SYSTEM
K031919
Ebi, L.P.
Orthopedic · 73d
Cleared Jul 30, 2003
MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES
K032058
Alliance Medical Corp.
Orthopedic · 28d
Cleared Jul 14, 2003
EXTERNAL FIXATION SYSTEMS
K031181
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jul 14, 2003
SYNTHES SMALL COBINATION CLAMP-MR SAFE
K031724
Synthes (Usa)
Orthopedic · 41d
Cleared Jul 10, 2003
EBI XFIX OPTIROM KNEE FIXATOR
K031093
Ebi, L.P.
Orthopedic · 94d
Cleared Jun 25, 2003
EBI XFIX DFS SYSTEM
K031645
Ebi, L.P.
Orthopedic · 28d
Cleared Jun 24, 2003
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
K031725
Synthes (Usa)
Orthopedic · 21d
Cleared Jun 06, 2003
SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE
K031573
Synthes (Usa)
Orthopedic · 17d