510(k) Report

Devices descending from K063049

468 later devices reach Synthes (Usa) Modular Mini Fragment LCP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+2K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+2K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+2K151468ARIX Wrist SystemJeil Medical Corporation20167—
+2K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+2K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+2K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+2K143721PRCT2Fx Solutions20150—
+2K142906APTUS Wrist 2.5 SystemMedartis AG201559—
+2K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+2K142581APTUS Foot SystemMedartis AG201522—
+2K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+2K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+2K141232Aptus Ulna Shortening 2.5Medartis AG201451
+2K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+2K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+2K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+2K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+2K140376Variax 2 SystemStryker Trauma AG201423—
+2K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+2K132594Crosscheck Plating SystemSolana Surgical, LLC20132321
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+2K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+2K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+2K123241Arthrex Fracture PlatesArthrex, Inc.201371—
+2K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+2K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+2K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+2K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+2K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+2K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+2K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+2K112437Arthrex Fracture SystemArthrex, Inc.201191—
+2K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+2K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+2K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.201177—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+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—
+3K254215Arthrex Beaming SystemArthrex, Inc.20261—
+3K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+3K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+3K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+3K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+3K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+3K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+3K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+3K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+3K243740Versalock Upper Limb Plating SystemGM Dos Reis Industria e Comercio Ltda.20251—
+3K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+3K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K242998GMReis Ankle Plating SystemGM Dos Reis Industria e Comercio Ltda.20241—
+3K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+3K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+3K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+3K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+3K240487EVOS Patella PlatesSmith & Nephew20240—
+3K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+3K241539Activmotion SNewclip Technics20240—
+3K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+3K230546SignexOsteonic Co., Ltd.20242—
+3K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+3K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+3K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+3K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+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—
+3K230204ALPHALOK Plating SystemVilex, LLC20230—
+3K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+3K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+3K221558ALPHALOK Plating SystemVilex, LLC20222—
+3K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+3K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+3K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+3K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+3K222244Arthrex 3.5 mm Locking Compression PlatesArthrex, Inc.20221—
+3K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231