510(k) Report

Devices descending from K014263

596 later devices reach Newgen/Universal Mandibular System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+5K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemMedcad20230—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K230938ARIX Humerus SystemJeil Medical Corporation20230—
+5K230204ALPHALOK Plating SystemVilex, LLC20230—
+5K221558ALPHALOK Plating SystemVilex, LLC20222—
+5K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+5K210731KLS Martin Individual Patient SolutionsKLS-Martin L.P.20223—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+5K203282TECHFIT Patient-Specific Maxillofacial SystemIndustrias Medicas Sampedro S.A.S20211—
+5K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+5K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+5K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+5K173135VariAx 2 SystemStryker GmbH201713—
+5K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+5K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+5K170124Level One Hand Plating SystemKLS Martin L.P.20172—
+5K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+5K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+5K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+5K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+5K153482KLS Martin Thoracic Plating SystemKLS-Martin L.P.20169—
+5K151983KLS Martin LSS Plating SystemKLS Martin L.P.201645—
+5K142484Sternal Closure SystemJace Medical, LLC20141—
+5K140309CranioplugOssdsign AB20142—
+5K122860KLS Martin Recon TalonKLS Martin L.P.201210—
+5K101484Compressyn BandDallen Medical20115—
+5K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20083421
+6K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+6K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+6K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+6K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+6K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, Inc.20240—
+6K232350Stryker Facial iD SystemStryker Craniomaxillofacial20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG20230—
+6K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+6K222397KLS Martin Level One Rib Fixation SystemKLS-Martin L.P.20233—
+6K221938KLS Martin Pure Pectus SystemKLS Martin L.P.20236—
+6K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+6K210290JACE Medical Thoracic Plating SystemJace Medical, LLC20210—
+6K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices202139—
+6K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+6K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+6K181539OSSDSIGN CranioplugOssdsign AB20181—
+6K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+6K130431Compressyn BandDallen Medical, Inc.20134—
+6K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc20129712
+6K102156Maxlock Extreme Extremity Plating System Distal Radius Plates and ScrewsOrthohelix Surgical Designs, Inc.20101191
+6K101962Mini Maxlock Extreme Plating SystemOrthohelix Surgical Designs, Inc.2010851
+6K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010228—
+6K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010339—
+7K261892ProRib Fixation SystemCosta Surgical, Inc.20260—
+7K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+7K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+7K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.20260—
+7K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+7K253660KLS Martin Pure Pectus SystemKLS-Martin L.P.20260—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K243357CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.20252—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K232515Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20230—
+7K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+7K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+7K211695Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D/B/A Able Medical Devices20211—
+7K200062Foot and Ankle SystemLeith Medical, LLC20210—
+7K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+7K200513DAC Dynamic Active Compression PlatePioneer Surgical Technology, Inc., Dba Rti Surgical20200—
+7K200226RetroFixRetrofix Screws, LLC20200—
+7K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+7K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+7K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+7K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+7K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+7K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—