510(k) Report

Devices descending from K980364

82 later devices reach Howmedica and Howmedica Leibinger Bone Screw Washers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062498Profyle SystemHowmedica Osteonics Corp.2006811
+2K253906Xpert HandNewclip Technics20260—
+2K191972ARIX Wrist SystemJeil Medical Corporation20190—
+2K181009APTUS CMC-I Fusion Plate SystemMedartis AG20180—
+2K180500VariAx 2 SystemStryker GmbH201812—
+2K132769Acumed Hand Plating SystemAcumed, LLC20147—
+2K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+2K131566Arix Hand SystemJeil Medical Corporation20138—
+2K073527Variax Elbow SystemHowmedica Osteonics Corp.200861—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+3K161746ARIX Hand SystemJeil Medical Corporation20161—
+3K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+3K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+3K132502Variax 2 SystemStryker Trauma AG201321—
+3K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+3K101056Variax Elbow SystemHowmedica Osteonics Corp.201058—
+3K093433Variax Elbow System Plate Line ExtensionHowmedica Osteonics Corp.20101—
+3K092671Variax Elbow System Line ExtensionHowmedica Osteonics Corp.20090—
+4K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+4K230204ALPHALOK Plating SystemVilex, LLC20230—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K221558ALPHALOK Plating SystemVilex, LLC20222—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+4K140769Variax 2 SystemStryker Trauma AG201419—
+4K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+4K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+4K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+5K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+5K201656ARIX Elbow SystemJeil Medical Corporation20200—
+5K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+5K173135VariAx 2 SystemStryker GmbH201713—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+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—
+6K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+6K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+6K172008ARIX Humerus SystemJeil Medical Corporation20173—
+7K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+7K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+7K230938ARIX Humerus SystemJeil Medical Corporation20230—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+7K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+8K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+8K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+10K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—