LXT · Class II · 21 CFR 888.3030

FDA Product Code LXT: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

Leading manufacturers include Synthes (Usa), Howmedica Osteonics Corp. and Immedica, Inc..

57
Total
57
Cleared
73d
Avg days
1986
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite Devices (Product Code LXT)

57 devices
1–24 of 57
Cleared Sep 22, 2023
Para-Fix External Fixation System
K230067
New Paradigm Biomedical
Orthopedic · 256d
Cleared Oct 10, 2013
POLARUS CONNECT
K131636
Acumed, LLC
Orthopedic · 128d
Cleared Oct 09, 2013
DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
K132704
Biomet
Orthopedic · 41d
Cleared Oct 31, 2011
DISTAL VOLAR RADIUS PLATING SYSTEMS
K112345
Medos International SARL
Orthopedic · 77d
Cleared Mar 11, 2009
STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S
K090374
DePuy Orthopaedics, Inc.
Orthopedic · 22d
Cleared Jan 29, 2008
SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
K073135
Synthes (Usa)
Orthopedic · 83d
Cleared Mar 07, 2007
SYNTHES (USA) ELBOW HINGE FIXATOR
K063832
Synthes (Usa)
Orthopedic · 71d
Cleared Apr 28, 2006
MULTIDIRECTIONAL THREADED PEG
K060864
Hand Innovations, LLC
Orthopedic · 29d
Cleared Mar 28, 2006
PTA (PROGRESSIVE TIBIAL ALIGNMENT)
K060403
Meridian Medical
Orthopedic · 41d
Cleared Feb 27, 2006
SHOULDER FIXATION SYSTEM
K060290
Hand Innovations, LLC
Orthopedic · 21d
Cleared Oct 27, 2005
WRIST FUSION PLATE
K052754
Dvo Extremity Solutions, LLC
Orthopedic · 27d
Cleared Jul 20, 2005
MODIFICATION TO SHOULDER FIXATION SYSTEM
K051728
Hand Innovations, LLC
Orthopedic · 23d
Cleared Jun 17, 2005
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K051306
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Apr 26, 2005
DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
K050932
Hand Innovations, Inc.
Orthopedic · 12d
Cleared Apr 11, 2005
SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION
K050631
Synthes (Usa)
Orthopedic · 31d
Cleared Oct 07, 2004
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
K042458
A.M. Surgical, Inc.
Orthopedic · 27d
Cleared Sep 30, 2004
SHOULDER FIXATION SYSTEM
K042059
Hand Innovations, Inc.
Orthopedic · 62d
Cleared Feb 20, 2004
SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES
K033805
Synthes (Usa)
Orthopedic · 74d
Cleared Nov 05, 2003
HOFFMANN II PELVIC CLAMP
K033145
Howmedica Osteonics Corp.
Orthopedic · 36d
Cleared Sep 05, 2003
SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE
K031973
Synthes (Usa)
Orthopedic · 71d
Cleared Aug 08, 2003
SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE
K031428
Synthes (Usa)
Orthopedic · 94d
Cleared Jul 25, 2003
STRYKER PLATING SYSTEM PERIARTICULAR PLATES
K031959
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Apr 01, 2003
SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE
K030390
Synthes (Usa)
Orthopedic · 55d
Cleared Oct 17, 2002
HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
K022651
Howmedica Osteonics Corp.
Orthopedic · 69d

About Product Code LXT - Regulatory Context

510(k) Submission Activity

57 total 510(k) submissions under product code LXT since 1986, with 57 receiving FDA clearance (average review time: 73 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.