510(k) Report

Devices descending from K062498

81 later devices reach Profyle System through their predicates, nearest generation first.

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