510(k) Report

Devices descending from K002619

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+6K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+6K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+6K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+6K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+6K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+6K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+6K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+6K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+6K240487EVOS Patella PlatesSmith & Nephew20240—
+6K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+6K241539Activmotion SNewclip Technics20240—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemMedcad20230—
+6K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+6K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K230938ARIX Humerus SystemJeil Medical Corporation20230—
+6K230204ALPHALOK Plating SystemVilex, LLC20230—
+6K221558ALPHALOK Plating SystemVilex, LLC20222—
+6K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+6K210731KLS Martin Individual Patient SolutionsKLS-Martin L.P.20223—
+6K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+6K203282TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S20211—
+6K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+6K181539OSSDSIGN CranioplugOssdsign AB20181—
+6K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+6K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+6K173135VariAx 2 SystemStryker GmbH201713—
+6K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+6K170124Level One Hand Plating SystemKLS Martin L.P.20172—
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+6K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+6K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+6K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+6K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+6K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+6K142484Sternal Closure SystemJace Medical, LLC20141—
+6K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+6K101484Compressyn BandDallen Medical20115—
+6K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20083421
+7K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+7K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+7K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+7K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+7K232350Stryker Facial iD SystemStryker Craniomaxillofacial20240—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+7K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+7K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+7K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+7K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+7K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+7K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+7K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+7K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+7K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+7K130431Compressyn BandDallen Medical, Inc.20134—
+7K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+7K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101191
+7K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2010851
+7K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+7K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010339—
+8K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+8K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+8K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+8K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.20260—
+8K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+8K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+8K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+8K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+8K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+8K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+8K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+8K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+8K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+8K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+8K200062Foot and Ankle SystemLeith Medical, LLC20210—
+8K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+8K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+8K200226RetroFixRetrofix Screws, LLC20200—
+8K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+8K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+8K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+8K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+8K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—