510(k) Report

Devices descending from K051567

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253906Xpert HandNewclip Technics20260—
+1K243469SignexOsteonic Co., Ltd.20250—
+1K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+1K232144Sterile Products of the APTUS SystemMedartis AG20233—
+1K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+1K213214Xpert WristNewclip Technics20210—
+1K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+1K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+1K181009APTUS CMC-I Fusion Plate SystemMedartis AG20180—
+1K180348Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.20183—
+1K171624IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH20180—
+1K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178—
+1K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+1K142906APTUS Wrist 2.5 SystemMedartis AG201559—
+1K141232Aptus Ulna Shortening 2.5Medartis AG201451
+1K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+1K132769Acumed Hand Plating SystemAcumed, LLC20147—
+1K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128—
+1K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+1K103332Aptus Ulna PlatesMedartis AG201171—
+1K102537Aptus 1.5 TrilockMedartis AG201019—
+1K062498Profyle SystemHowmedica Osteonics Corp.2006811
+2K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+2K260761APTUS Clavicle System 2.8Medartis AG20260—
+2K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+2K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+2K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+2K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+2K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+2K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+2K241695Extremity All Suture SystemField Orthopaedics20240—
+2K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+2K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+2K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+2K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+2K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+2K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.20235—
+2K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+2K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc.20200—
+2K201656ARIX Elbow SystemJeil Medical Corporation20200—
+2K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+2K191972ARIX Wrist SystemJeil Medical Corporation20190—
+2K192297APTUS Wrist Arthrodesis PlatesMedartis AG20197—
+2K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+2K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+2K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+2K180500VariAx 2 SystemStryker GmbH201812—
+2K170843Alians Fragment SpecificNewclip Technics20171—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K161861APTUS® Coronoid 2.0Medartis AG20170—
+2K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+2K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+2K151468ARIX Wrist SystemJeil Medical Corporation20167—
+2K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+2K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+2K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+2K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+2K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+2K131566Arix Hand SystemJeil Medical Corporation20138—
+2K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+2K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+2K073527Variax Elbow SystemHowmedica Osteonics Corp.200861—
+3K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+3K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+3K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+3K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+3K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+3K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+3K240487EVOS Patella PlatesSmith & Nephew20240—
+3K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+3K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+3K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+3K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+3K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+3K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—