510(k) Report

Devices descending from K002619

597 later devices reach Newgen System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+8K142581APTUS Foot SystemMedartis AG201522—
+8K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+8K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+8K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+8K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+8K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+8K140376Variax 2 SystemStryker Trauma AG201423—
+8K133858Tensyn BandDallen Medical, Inc.20143—
+8K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+8K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc201295—
+8K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+8K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+8K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+8K120157Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.201264—
+8K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+8K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+8K113048Maxlock Extreme SystemOrthohelix Surgical Designs, Inc.201252—
+8K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+8K111041Mini Variable SystemOrthohelix Surgical Designs, Inc.201177—
+9K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20260—
+9K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+9K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+9K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+9K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+9K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+9K242988Genostis Osteosynthesis SystemGenostis AF20250—
+9K250892CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20251—
+9K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+9K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+9K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+9K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+9K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+9K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+9K221395Footmotion Plating SystemNewclip Technics20220—
+9K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+9K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+9K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+9K211435PAO Cortical ScrewMedacta International S.A.20210—
+9K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+9K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+9K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+9K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+9K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+9K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+9K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep20192—
+9K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+9K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+9K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+9K191636APTUS Foot SystemMedartis AG20190—
+9K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+9K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+9K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+9K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+9K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+9K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+9K172886Breakaway Screw SystemParagon 2820174—
+9K172300CoLink View Plating SystemIn2bones USA, LLC201716—
+9K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+9K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+9K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+9K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+9K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+9K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+9K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+9K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+9K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+9K161448Footmotion Plating SystemNewclip Technics20165—
+9K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+9K161037Tarsa-Link Stand-Alone Wedge Fixation SystemLife Spine, Inc.20169—
+9K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+9K153379AxSOS 3TiStryker GmbH201625—
+9K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+9K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+9K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+9K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+9K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+9K151442Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc201523—
+9K151407RECON systemNormed Medizin-Technik GmbH20154—
+9K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+9K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+9K151235Medline Foot Plates and ScrewsMedline Industries, Inc.201510—
+9K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+9K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+9K143365Eminent Foot Plate SystemEminent Spine20151—
+9K143717Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.201512—
+9K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+9K143025Total Compression Plating SystemWrightmedicaltechnologyinc201424—
+9K141905Pro-Link Wedge SystemLife Spine201411—
+9K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411