510(k) Report

Devices descending from K002775

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+3K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+3K073527Variax Elbow SystemHowmedica Osteonics Corp.200861—
+3K061917Distal Radius Locking Plating SystemNewclip Technics20066—
+3K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003615—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+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—
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+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—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+4K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+4K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+4K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+4K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+4K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+4K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K173746Activmotion RangeNewclip Technics20181—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172350AxSOS 3 TiStryker GmbH201717—
+4K172008ARIX Humerus SystemJeil Medical Corporation20173—
+4K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K170705ARIX Wrist SystemJeil Medical Corporation20172—
+4K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+4K161746ARIX Hand SystemJeil Medical Corporation20161—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+4K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+4K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+4K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+4K132502Variax 2 SystemStryker Trauma AG201321—
+4K130774Universal Distal Radius SystemNewclip Technics20135—
+4K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.201238—
+4K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+4K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+4K101056Variax Elbow SystemHowmedica Osteonics Corp.201058—
+4K093433Variax Elbow System Plate Line ExtensionHowmedica Osteonics Corp.20101—
+4K092671Variax Elbow System Line ExtensionHowmedica Osteonics Corp.20090—
+4K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20056061
+4K042437Dorsal Intramedullary PlateDeo Volente Orthopaedics, LLC20047—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+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—
+5K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K230938ARIX Humerus SystemJeil Medical Corporation20230—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230204ALPHALOK Plating SystemVilex, LLC20230—
+5K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—