510(k) Report

Devices descending from K023007

681 later devices reach Distal Radius Fracture Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K173746Activmotion RangeNewclip Technics20181—
+4K172008ARIX Humerus SystemJeil Medical Corporation20173—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K170705ARIX Wrist SystemJeil Medical Corporation20172—
+4K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K161746ARIX Hand SystemJeil Medical Corporation20161—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+4K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+4K133939Modified Distal Radius Plating SystemBiomet2014112
+4K132502Variax 2 SystemStryker Trauma AG201321—
+4K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+4K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+4K101056Variax Elbow SystemHowmedica Osteonics Corp.201058—
+4K093433Variax Elbow System Plate Line ExtensionHowmedica Osteonics Corp.20101—
+4K092671Variax Elbow System Line ExtensionHowmedica Osteonics Corp.20090—
+4K090374Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…DePuy Orthopaedics, Inc.200918—
+4K071809Ensplintrx Bone Fixation SystemSonoma Orthopedic Products, Inc.20086—
+4K060864Multidirectional Threaded PegHand Innovations, LLC200618—
+4K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005584—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+5K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K230938ARIX Humerus SystemJeil Medical Corporation20230—
+5K230204ALPHALOK Plating SystemVilex, LLC20230—
+5K221558ALPHALOK Plating SystemVilex, LLC20222—
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+5K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+5K141493Proximal Humerus Plating SystemMiami Device Solutions201571
+5K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+5K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+5K140769Variax 2 SystemStryker Trauma AG201419—
+5K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+5K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+5K131636Polarus ConnectAcumed, LLC20130—
+5K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+5K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+5K102689Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics20134—
+5K122737Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20123—
+5K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+5K100325Peri-Loc Locking Hole Inserts and Cable AccessoriesSmith & Nephew, Inc.201038—
+5K090304Waveon WRX Bone Fixation SystemSonoma Orthopedic Products, Inc.20090—
+5K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2009411
+5K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.2009605
+5K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.2009772
+5K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.200887—
+5K081106Peri-Loc Periarticular Locked Plating System Volar Distal Radius Locking Plate for the…Smith & Nephew, Inc.200834—
+5K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007495—
+5K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006108—
+5K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH2006272
+5K060041Trimed Bone PlatesTriMed, Inc.2006263
+6K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+6K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+6K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+6K242079Arthrex Elbow Fracture Plating SystemArthrex, Inc.20240—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+6K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+6K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+6K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc.20213—
+6K201918EVOS Large Fragment Plating SystemSmith & Nephew, Inc.202044