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 Biomet, 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 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 Jun 17, 2005
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
K051306
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Apr 11, 2005
SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION
K050631
Synthes (Usa)
Orthopedic · 31d
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
Cleared Jul 13, 2001
HOFFMAN II HYBRID RING CLAMP
K011948
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Dec 29, 2000
BIOMET EXTERNAL WRIST PLATE
K003240
Biomet, Inc.
Orthopedic · 73d
Cleared Dec 18, 2000
DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM
K002923
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 15, 2000
HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING
K003211
Howmedica Osteonics Corp.
Orthopedic · 63d
Cleared Aug 31, 2000
RADIOLUCENT COLLES FRACTURE KIT
K001760
Biomet, Inc.
Orthopedic · 83d
Cleared Aug 17, 2000
SYNTHES SCALLOPED DISTAL TIBIA PLATE
K001793
Synthes (Usa)
Orthopedic · 64d
Cleared Jun 16, 2000
SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
K000972
Synthes (Usa)
Orthopedic · 81d
Cleared May 23, 2000
HOFFMANN II EXTERNAL FIXATION SYSTEM
K000957
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Apr 14, 2000
SYNTHES (USA) WRIST FUSION PLATES (WFP)
K000558
Synthes (Usa)
Orthopedic · 56d
Cleared Jun 11, 1999
SYNTHES LOCKING CALCANEAL PLATES
K991407
Synthes (Usa)
Orthopedic · 50d
Cleared Nov 12, 1996
SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
K963618
Synthes (Usa)
Orthopedic · 63d

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.