510(k) Report

Devices descending from K060613

341 later devices reach Variax Locking Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+4K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+4K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+4K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+4K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+4K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+4K220136Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20228—
+4K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K211435PAO Cortical ScrewMedacta International S.A.20210—
+4K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+4K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+4K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+4K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+4K202959PolyLock Plating SystemFusion Orthopedics, LLC20201—
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+4K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+4K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K192696TriMed ASET Foot Plating SystemTriMed, Inc.20201—
+4K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+4K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+4K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+4K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K192504Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201910—
+4K191636APTUS Foot SystemMedartis AG20190—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+4K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+4K181820Medline Unite Mini Plates and ScrewsMedline Industries, Inc.20182—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K171690Trident Extremity Fixation SystemTrident Orthopedics20180—
+4K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+4K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172886Breakaway Screw SystemParagon 2820174—
+4K172350AxSOS 3 TiStryker GmbH201717—
+4K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+4K171510Footmotion Plating SystemNewclip Technics20171—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K170012Foot and Hand MotionNewclip Technics20170—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+4K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+4K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+4K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K153531Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201611—
+4K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+4K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+4K150368Tarsa-Link Wedge Fixation SystemLife Spine201510—
+4K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+4K141992Variax 2 SystemStryker Trauma AG201422—
+4K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+4K123203Maxlock Extreme System Model MXLOrthohelix Surgical Designs, Inc.201238—
+4K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+4K121437Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201238—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261191Alians Elbow SNewclip Technics20260—
+5K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+5K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+5K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+5K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+5K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP20250—
+5K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+5K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—