510(k) Report

Devices descending from K092038

91 later devices reach Aptus K-Wire System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+1K232144Sterile Products of the APTUS SystemMedartis AG20233—
+1K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+1K181425APTUS® Proximal Humerus SystemMedartis AG20181—
+1K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+1K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+1K103332Aptus Ulna PlatesMedartis AG201171—
+2K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+2K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+2K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+2K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+2K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+2K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc.20200—
+2K201656ARIX Elbow SystemJeil Medical Corporation20200—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+2K151468ARIX Wrist SystemJeil Medical Corporation20167—
+2K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+2K142906APTUS Wrist 2.5 SystemMedartis AG201559—
+2K150626Rush Medullary PinsZimmer, Inc.20150—
+2K141232Aptus Ulna Shortening 2.5Medartis AG201451
+2K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+2K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K260761APTUS Clavicle System 2.8Medartis AG20260—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.20235—
+3K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+3K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K213214Xpert WristNewclip Technics20210—
+3K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+3K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K191972ARIX Wrist SystemJeil Medical Corporation20190—
+3K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+3K172008ARIX Humerus SystemJeil Medical Corporation20173—
+3K170705ARIX Wrist SystemJeil Medical Corporation20172—
+3K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178—
+3K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K161861APTUS® Coronoid 2.0Medartis AG20170—
+3K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+4K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+4K230938ARIX Humerus SystemJeil Medical Corporation20230—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+4K173746Activmotion RangeNewclip Technics20181—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+5K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+5K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+5K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+5K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—