510(k) Report

Devices descending from K040022

202 later devices reach Stryker Leibinger Universal Distal Radius System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc.20200—
+3K201656ARIX Elbow SystemJeil Medical Corporation20200—
+3K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+3K192297APTUS Wrist Arthrodesis PlatesMedartis AG20197—
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+3K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—
+3K173746Activmotion RangeNewclip Technics20181—
+3K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+3K172008ARIX Humerus SystemJeil Medical Corporation20173—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K170705ARIX Wrist SystemJeil Medical Corporation20172—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+3K161746ARIX Hand SystemJeil Medical Corporation20161—
+3K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+3K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+3K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+3K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+3K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+3K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+3K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+3K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+3K140769Variax 2 SystemStryker Trauma AG201419—
+3K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+3K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+3K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+3K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+3K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+4K262975Arthrex Beaming SystemArthrex, Inc.20260—
+4K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K230938ARIX Humerus SystemJeil Medical Corporation20230—
+4K230204ALPHALOK Plating SystemVilex, LLC20230—
+4K221558ALPHALOK Plating SystemVilex, LLC20222—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+4K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+4K173135VariAx 2 SystemStryker GmbH201713—
+4K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+5K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+5K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—