510(k) Report

Devices descending from K051567

157 later devices reach Aptus Titanium Osteosynthesis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K173746Activmotion RangeNewclip Technics20181—
+3K172008ARIX Humerus SystemJeil Medical Corporation20173—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K170705ARIX Wrist SystemJeil Medical Corporation20172—
+3K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+3K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K161746ARIX Hand SystemJeil Medical Corporation20161—
+3K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+3K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+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—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K230938ARIX Humerus SystemJeil Medical Corporation20230—
+4K230204ALPHALOK Plating SystemVilex, LLC20230—
+4K221558ALPHALOK Plating SystemVilex, LLC20222—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+4K140769Variax 2 SystemStryker Trauma AG201419—
+4K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+4K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+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—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+5K200226RetroFixRetrofix Screws, LLC20200—
+5K173135VariAx 2 SystemStryker GmbH201713—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—