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
241–264 of 404
Cleared Feb 22, 2002
SLIM GLIDING NAIL SYSTEM
K020240
Plus Orthopedics
Orthopedic · 30d
Cleared Feb 05, 2002
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K020141
Ebi, L.P.
Orthopedic · 20d
Cleared Jan 17, 2002
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K014194
Ebi, L.P.
Orthopedic · 27d
Cleared Nov 20, 2001
EBI XFIX ACCESS PELVIC FIXATOR
K013540
Ebi, L.P.
Orthopedic · 27d
Cleared Nov 16, 2001
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
K013503
DePuy Orthopaedics, Inc.
Orthopedic · 25d
Cleared Nov 08, 2001
EBI XFIX DFS SYSTEM
K013378
Ebi, L.P.
Orthopedic · 27d
Cleared Jul 25, 2001
EBI XFIX DFS SYSTEM
K012024
Ebi, L.P.
Orthopedic · 27d
Cleared Jun 29, 2001
MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM
K011711
Ebi, L.P.
Orthopedic · 25d
Cleared Jun 27, 2001
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
K011034
Synthes (Usa)
Orthopedic · 83d
Cleared Jun 27, 2001
EBI XFIX ACCESS PELVIC FIXATOR
K011697
Ebi, L.P.
Orthopedic · 26d
Cleared Jun 12, 2001
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
K010766
Synthes (Usa)
Orthopedic · 90d
Cleared May 23, 2001
SYNTHES ANTEROLATERAL CALCANEAL PLATE
K010518
Synthes (Usa)
Orthopedic · 90d
Cleared May 03, 2001
ADJUSTABLE LARGE FIXATOR SYSTEM
K010344
Synthes (Usa)
Orthopedic · 87d
Cleared Mar 13, 2001
MODIFICATION TO EBI XFIX DFS RAIL SYSTEM
K010437
Ebi, L.P.
Orthopedic · 28d
Cleared Jan 29, 2001
COLLES C SERIES FRAME STERILE PACK
K003397
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared May 23, 2000
EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM
K001358
Ebi, L.P.
Orthopedic · 25d
Cleared May 05, 2000
PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601
K000734
Pioneer Surgical Technology
Orthopedic · 59d
Cleared May 01, 2000
SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000682
Synthes (Usa)
Orthopedic · 62d
Cleared Apr 28, 2000
SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000684
Synthes (Usa)
Orthopedic · 59d
Cleared Feb 25, 2000
EBI XFIX DFS SYSTEM
K000319
Ebi, L.P.
Orthopedic · 23d
Cleared Feb 03, 2000
EBI XFIX DFS RAIL SYSTEM
K000083
Ebi, L.P.
Orthopedic · 22d
Cleared Jan 03, 2000
ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
K993873
Alphatec Mfg., Inc.
Orthopedic · 49d
Cleared Dec 20, 1999
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
K993289
Smith & Nephew, Inc.
Orthopedic · 80d
Cleared Dec 14, 1999
EBI XFIX VISION FIXATION SYSTEM
K993886
Ebi, L.P.
Orthopedic · 28d