Atlas FDA

LXT

57 FDA 510(k) clearances · Product code

63 daysmedian time to decision
128 days90th percentile
57clearances measured

FDA profile

Official device name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2019: 40 · 2020: 32 · 2021: 24 · 2022: 21 · 2023: 18 · 2024: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Para-Fix External Fixation System (K230067)New Paradigm Biomedical2023-09-22
POLARUS CONNECT (K131636)Acumed, LLC2013-10-10
DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW (K132704)Biomet2013-10-09
DISTAL VOLAR RADIUS PLATING SYSTEMS (K112345)Medos International SARL2011-10-31
STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S (K090374)DePuy Orthopaedics, Inc.2009-03-11
SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS (K073135)Synthes (Usa)2008-01-29
SYNTHES (USA) ELBOW HINGE FIXATOR (K063832)Synthes (Usa)2007-03-07
MULTIDIRECTIONAL THREADED PEG (K060864)Hand Innovations, LLC2006-04-28
PTA (PROGRESSIVE TIBIAL ALIGNMENT) (K060403)Meridian Medical2006-03-28
SHOULDER FIXATION SYSTEM (K060290)Hand Innovations, LLC2006-02-27
WRIST FUSION PLATE (K052754)Dvo Extremity Solutions, LLC2005-10-27
MODIFICATION TO SHOULDER FIXATION SYSTEM (K051728)Hand Innovations, LLC2005-07-20
HOFFMANN II MRI EXTERNAL FIXATION SYSTEM (K051306)Howmedica Osteonics Corp.2005-06-17
DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM (K050932)Hand Innovations, Inc.2005-04-26
SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION (K050631)Synthes (Usa)2005-04-11
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM (K042458)A.M. Surgical, Inc.2004-10-07
SHOULDER FIXATION SYSTEM (K042059)Hand Innovations, Inc.2004-09-30
SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES (K033805)Synthes (Usa)2004-02-20
HOFFMANN II PELVIC CLAMP (K033145)Howmedica Osteonics Corp.2003-11-05
DISTAL RADIUS FRACTURE REPAIR SYSTEM (K032705)Hand Innovations, Inc.2003-10-01
CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) (K032169)Cyberorthology, Inc.2003-09-22
SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE (K031973)Synthes (Usa)2003-09-05
SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE (K031428)Synthes (Usa)2003-08-08
STRYKER PLATING SYSTEM PERIARTICULAR PLATES (K031959)Howmedica Osteonics Corp.2003-07-25
SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE (K030390)Synthes (Usa)2003-04-01
HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT (K022651)Howmedica Osteonics Corp.2002-10-17
NBX - NON-BRIDGING EXTERNAL FIXATOR (K020905)Biomet Orthopedics, Inc.2002-04-15
MODIFICATION TO EBI XFIX DFS SYSTEM (K013739)Ebi, L.P.2001-12-13
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM (K013772)Howmedica Osteonics2001-12-03
HOFFMAN II HYBRID RING CLAMP (K011948)Howmedica Osteonics Corp.2001-07-13
BIOMET EXTERNAL WRIST PLATE (K003240)Biomet, Inc.2000-12-29
DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM (K002923)Howmedica Osteonics Corp.2000-12-18
TRANSFX ANGLED RODS (K003205)Immedica, Inc.2000-12-15
HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING (K003211)Howmedica Osteonics Corp.2000-12-15
RADIOLUCENT COLLES FRACTURE KIT (K001760)Biomet, Inc.2000-08-31
SYNTHES SCALLOPED DISTAL TIBIA PLATE (K001793)Synthes (Usa)2000-08-17
SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS (K000972)Synthes (Usa)2000-06-16
TRANS FX ADJUSTABLE PIN TO BAR CLAMP (K001084)Immedica, Inc.2000-06-15
HOFFMANN II EXTERNAL FIXATION SYSTEM (K000957)Howmedica Osteonics Corp.2000-05-23
SYNTHES (USA) WRIST FUSION PLATES (WFP) (K000558)Synthes (Usa)2000-04-14
ULTIMAX HAIG II NAIL SYSTEM (K991889)Encore Orthopedics, Inc.1999-08-12
TRANSFX MULTI PIN CLAMP (K991723)Immedica, Inc.1999-07-22
SYNTHES LOCKING CALCANEAL PLATES (K991407)Synthes (Usa)1999-06-11
TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION (K990848)Immedica, Inc.1999-05-17
TRANSFX EXTERNAL FIXATION SYSTEM (K984357)Immedica, Inc.1999-03-04
DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI (K974245)Depuy Ace Medical Co.1998-05-22
GUIDE WIRES FOR CANNULATED SCREWS (K963432)Orthopaedic Biosystems, Ltd.1996-11-13
SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF) (K963618)Synthes (Usa)1996-11-12
EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM (K962846)Biodynamic Technologies, Inc.1996-10-23
BERLIN EXTERNAL FIXATOR (K954053)Encore Orthopedics, Inc.1996-05-16
TITANIUM UNIVERSAL CLAMP (K960269)Synthes (Usa)1996-04-04
ACE-DUPONT COMPOSITE RINGS (K955388)Ace Medical Co.1996-01-31
HEX-FIX FIELD FIXATOR (K953397)Smith & Nephew Richards, Inc.1995-10-31
SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR (K950384)Synthes (Usa)1995-05-22
TRUE/LOK MONOLATERAL/BILATERAL FIXATOR (K941048)Applied Osteo Systems, Inc.1994-10-03
ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY (K874377)Harrington Arthritis Research Center1988-05-20
MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM (K864403)Howmedica Corp.1986-12-18

Track LXT automatically

Every clearance here is in the API, with alerts when new ones post.