510(k) Report

Devices descending from K041081

257 later devices reach Fragment Plate System, Screws, Pins and K-Wires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+1K061748Fragment Plate SystemHand Innovations, LLC2006157—
+1K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc.20051571
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K253906Xpert HandNewclip Technics20260—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+2K232144Sterile Products of the APTUS SystemMedartis AG20233—
+2K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+2K213214Xpert WristNewclip Technics20210—
+2K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+2K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+2K181009APTUS CMC-I Fusion Plate SystemMedartis AG20180—
+2K180348Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.20183—
+2K171624IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH20180—
+2K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+2K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178—
+2K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+2K142906APTUS Wrist 2.5 SystemMedartis AG201559—
+2K141232Aptus Ulna Shortening 2.5Medartis AG201451
+2K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+2K132769Acumed Hand Plating SystemAcumed, LLC20147—
+2K1318672.5MM Inline Fusion PlateBiomet, Inc.20130—
+2K131670Lapidus Plate, 3.5MM Inline Fusion Plate, 3.5MM MTP Plate (Left and Right)Biomet, Inc.20135—
+2K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+2K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128—
+2K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+2K103332Aptus Ulna PlatesMedartis AG201171—
+2K102537Aptus 1.5 TrilockMedartis AG201019—
+2K101240Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22…DePuy Orthopaedics, Inc.2010154—
+2K062498Profyle SystemHowmedica Osteonics Corp.2006811
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K260761APTUS Clavicle System 2.8Medartis AG20260—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+3K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+3K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+3K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+3K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K241695Extremity All Suture SystemField Orthopaedics20240—
+3K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+3K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+3K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+3K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.20235—
+3K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+3K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc.20200—
+3K201656ARIX Elbow SystemJeil Medical Corporation20200—
+3K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+3K191972ARIX Wrist SystemJeil Medical Corporation20190—
+3K192297APTUS Wrist Arthrodesis PlatesMedartis AG20197—
+3K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+3K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+3K182201Stratum™ Foot Plating SystemNextremity Solutions, Inc.201845
+3K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+3K180500VariAx 2 SystemStryker GmbH201812—
+3K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+3K173135VariAx 2 SystemStryker GmbH201713—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K161861APTUS® Coronoid 2.0Medartis AG20170—
+3K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+3K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+3K151468ARIX Wrist SystemJeil Medical Corporation20167—
+3K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+3K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+3K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+3K140376Variax 2 SystemStryker Trauma AG201423—
+3K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+3K131566Arix Hand SystemJeil Medical Corporation20138—
+3K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+3K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+3K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+3K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+3K073527Variax Elbow SystemHowmedica Osteonics Corp.200861—
+4K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—