510(k) Report

Devices descending from K103332

71 later devices reach Aptus Ulna Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243469SignexOsteonic Co., Ltd.20250—
+1K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+1K232144Sterile Products of the APTUS SystemMedartis AG20233—
+1K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+1K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc.20200—
+1K201656ARIX Elbow SystemJeil Medical Corporation20200—
+1K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+1K151468ARIX Wrist SystemJeil Medical Corporation20167—
+1K142906APTUS Wrist 2.5 SystemMedartis AG201559—
+1K141232Aptus Ulna Shortening 2.5Medartis AG201451
+1K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+1K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+2K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+2K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+2K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+2K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.20235—
+2K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+2K213214Xpert WristNewclip Technics20210—
+2K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+2K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+2K191972ARIX Wrist SystemJeil Medical Corporation20190—
+2K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+2K172008ARIX Humerus SystemJeil Medical Corporation20173—
+2K170705ARIX Wrist SystemJeil Medical Corporation20172—
+2K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178—
+2K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+2K170843Alians Fragment SpecificNewclip Technics20171—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K161861APTUS® Coronoid 2.0Medartis AG20170—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+3K260761APTUS Clavicle System 2.8Medartis AG20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+3K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+3K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+3K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+3K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+3K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+3K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+3K230938ARIX Humerus SystemJeil Medical Corporation20230—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—