510(k) Report

Devices descending from K981372

710 later devices reach Synthes 3.0 MM PC-Fix System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+5K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251—
+5K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K240181Clavicle and Scapula SystemAuxein Medical Pvt., Ltd.20240—
+5K241942TriMed Bridge PlatesTriMed, Inc.20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH20240—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+5K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+5K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+5K221342REDEMPTION Beaming SystemVilex, LLC20220—
+5K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+5K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K201510Traufix osteosynthesis, osteotomy, and arthrodesis devicesFixier S.A. DE C.V.20220—
+5K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+5K213572JuniOrtho Plating System™Orthofix Srl20220—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K213214Xpert WristNewclip Technics20210—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K202326BESPA Charcot SystemBespa Global, LLC20210—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+5K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+5K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+5K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+5K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+5K200062Foot and Ankle SystemLeith Medical, LLC20210—
+5K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+5K202307Activ FuseNewclip Technics20200—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+5K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+5K193368Smart Correction SystemWishbone Medical, Inc.202031
+5K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+5K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+5K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K193029Conquest FNSmith & Nephew, Inc.202010—
+5K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+5K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+5K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+5K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+5K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+5K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC20191—
+5K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+5K190586Monster® Screw SystemParagon 28, Inc.201921—
+5K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+5K182154Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC20181—
+5K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+5K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+5K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+5K173746Activmotion RangeNewclip Technics20181—
+5K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…Truemed Group, LLC20180—
+5K172785Conquest FNSmith & Nephew20178—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+5K170843Alians Fragment SpecificNewclip Technics20171—
+5K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+5K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+5K162380Locking Plate SystemBeijing Keyi Medical Device Technology Co., Ltd.20170—
+5K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+5K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+5K170310Alians Clavicle rangeNewclip Technics20170—
+5K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+5K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+5K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+5K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+5K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+5K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+5K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+5K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+5K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+5K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+5K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+5K160995NEOVIEW Plating SystemIn2bones Sas201624
+5K153379AxSOS 3TiStryker GmbH201625—
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+5K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+5K152686Conquest FNSmith & Nephew201612—