510(k) Report

Devices descending from K002619

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032520Ortrautek Trauma SystemTekka20030—
+1K022185Universal CMF SystemStryker Instruments200233—
+1K014263Newgen/Universal Mandibular SystemStryker Instruments20025961
+2K220360Tandry CMF Plate SystemMicroware Precision Co., Ltd.20220—
+2K221855Universal CMF SystemStryker Leibinger GmbH & Co KG20221—
+2K170773Stryker Universal MeshStryker20171—
+2K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsStryker20170—
+2K171364MP LeFort I PlatesStryker20170—
+2K161821Stryker Universal MeshStryker20162—
+2K132519Stryker Customized Mandible Recon Plate KitStryker20133—
+2K091807Medpor Fixation SystemPorex Surgical, Inc.20100—
+2K080694Osteomed Modular Locking Fixation SystemOsteomed LP20082—
+2K072463Satyrne Interflex Mandibular Fixation SystemSatyrne Medical20070—
+2K041651Stryker Leibinger Skeletal Anchoring SystemStryker Leibinger20044—
+2K040022Stryker Leibinger Universal Distal Radius SystemStryker Leibinger2004202—
+2K031659Universal Neuro SystemStryker Instruments200312—
+2K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP2003444—
+3K240651MRI UniversalStryker Leibinger GmbH & Co KG20240—
+3K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+3K193136Stryker Customized Mandible Recon Plate KitStryker20201—
+3K190696Stryker Surgeon iD Mandible Recon PlateStryker20190—
+3K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+3K182425Universal Mesh - SterileStryker Leibinger GmbH & Co KG201801
+3K170725Stryker Universal MeshStryker20170—
+3K142906APTUS Wrist 2.5 SystemMedartis AG201559—
+3K143338Argulated Locking PlatesOsteomed LP20150—
+3K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC20150—
+3K133974Variax Distal Radius Plating SystemStryker Leibinger GmbH201420—
+3K133246Zimmer Distal Radius Plating SystemZimmer, Inc.20132—
+3K131474Arthrex Distal Radius Plate SystemArthrex, Inc.201320—
+3K120015Osteomed Wrist Plating SystemOsteomed LP20122—
+3K112557Stryker Universal Neuro 3 SystemStryker20129—
+3K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics201156—
+3K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.20100—
+3K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp.201080—
+3K091051Bollard Miniplate Skeletal Anchorage SystemTita-Link20091—
+3K090522Osteomed Hand Plate and Screw Fixation SystemOsteomed LP200915—
+3K073527Variax Elbow SystemHowmedica Osteonics Corp.200861—
+3K071612Modus Trilock 2.0/2.3/2.5Medartis AG20070—
+3K063386Lorenz Orthodontic Anchorage SystemWalter Lorenz Surgical, Inc.20070—
+3K062498Profyle SystemHowmedica Osteonics Corp.2006811
+3K051798Osteomed Orthodontic Anchor Plating SystemOsteomed LP20060—
+3K051567Aptus Titanium Osteosynthesis SystemMedartis, Inc.20051571
+3K042766Orthofix Volar Distal Radial PlateOrthofix, Inc.20041—
+3K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P.2003435—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K253906Xpert HandNewclip Technics20260—
+4K243469SignexOsteonic Co., Ltd.20250—
+4K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+4K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+4K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.20241—
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K232144Sterile Products of the APTUS SystemMedartis AG20233—
+4K222624KLS Martin LINOS Wrist SystemKLS-Martin L.P.20235—
+4K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+4K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf)20220—
+4K222267Arthrex 2.4 mm Volar Distal Radius Plate SystemArthrex, Inc.20221—
+4K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K213214Xpert WristNewclip Technics20210—
+4K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+4K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+4K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLC20200—
+4K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemMedartis AG20208—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K191972ARIX Wrist SystemJeil Medical Corporation20190—
+4K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+4K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+4K173623Anchor plateBiomaterials Korea, Inc.20180—
+4K181009APTUS CMC-I Fusion Plate SystemMedartis AG20180—
+4K180962KLS Martin Individual Patient SolutionsKLS-Martin L.P.20180—
+4K180348Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.20183—
+4K180500VariAx 2 SystemStryker GmbH201812—
+4K171624IXOS Radius Plate SystemStuckenbrock Medizintechnik GmbH20180—
+4K163579KLS Martin Individual Patient SolutionsKLS Martin L.P.20179—
+4K172170APTUS (R) Wrist 2.5 SystemMedartis AG20178—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K161861APTUS® Coronoid 2.0Medartis AG20170—
+4K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.Gpc Medical, Ltd.201615—
+4K151468ARIX Wrist SystemJeil Medical Corporation20167—
+4K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+4K151387Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver BladeStryker20152—
+4K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+4K143749Arthrex Distal Radius SystemArthrex, Inc.20152—
+4K141301Maxlock Extreme Elbow Fracture SystemOrthohelix Surgical Designs, Inc.20140—
+4K141232Aptus Ulna Shortening 2.5Medartis AG201451
+4K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+4K132769Acumed Hand Plating SystemAcumed, LLC20147—
+4K132876Arix Hand Locking SystemJeil Medical Corporation20130—
+4K131566Arix Hand SystemJeil Medical Corporation20138—
+4K132502Variax 2 SystemStryker Trauma AG201321—
+4K131775Universal Neuro 3 SystemStryker20130—
+4K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation2013111
+4K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+4K120352Stryker Quikflap Sterile Procedure PackStryker2012418
+4K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics201240—
+4K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128—
+4K111419Osteomed Hand Fusion SystemOsteomed LP20111—
+4K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—