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
217–240 of 404
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
Cleared Mar 06, 2003
MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
K030372
Ebi, L.P.
Orthopedic · 30d
Cleared Feb 03, 2003
REPROCESSED EXTERNAL FIXATION DEVICE
K023714
Alliance Medical Corp.
Orthopedic · 90d
Cleared Jan 23, 2003
SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K023941
Synthes (Usa)
Orthopedic · 58d
Cleared Jan 22, 2003
MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM
K024248
Ebi, L.P.
Orthopedic · 30d
Cleared Jan 15, 2003
MODIFICATION TO EBI XFIX DFS SYSTEM
K024129
Ebi, L.P.
Orthopedic · 30d
Cleared Oct 25, 2002
EBI XFIX DFS SYSTEM
K023399
Ebi, L.P.
Orthopedic · 16d
Cleared Oct 18, 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K023324
Ebi, L.P.
Orthopedic · 14d
Cleared Aug 26, 2002
TEMPFIX EXTERNAL FIXATION SYSTEM
K021933
DePuy Orthopaedics, Inc.
Orthopedic · 75d
Cleared Aug 12, 2002
EBI XFIX DFS SYSTEM
K022319
Ebi, L.P.
Orthopedic · 26d
Cleared Jun 24, 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012623
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES
K012648
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 20, 2002
EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
K021695
Ebi, L.P.
Orthopedic · 29d
Cleared Jun 05, 2002
OMEGA II SYSTEM
K020772
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared May 23, 2002
EBI DFS OPTIROM ELBOW FIXATOR
K021312
Ebi, L.P.
Orthopedic · 28d
Cleared May 16, 2002
EBI XFIX RAIL SYSTEM
K021031
Ebi, L.P.
Orthopedic · 48d
Cleared May 03, 2002
EBI XFIX DFS SYSTEM
K021091
Ebi, L.P.
Orthopedic · 29d
Cleared Mar 08, 2002
MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR
K020403
Ebi, L.P.
Orthopedic · 29d
Cleared Mar 01, 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K014276
Ebi, L.P.
Orthopedic · 64d