510(k) Report

Devices descending from K002619

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K103332Aptus Ulna PlatesMedartis AG201171—
+4K102537Aptus 1.5 TrilockMedartis AG201019—
+4K101936Contours VSP Iii Volar Plating SystemOrthofix, Inc.20100—
+4K101056Variax Elbow SystemHowmedica Osteonics Corp.201058—
+4K093433Variax Elbow System Plate Line ExtensionHowmedica Osteonics Corp.20101—
+4K092671Variax Elbow System Line ExtensionHowmedica Osteonics Corp.20090—
+4K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P.200665—
+4K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004360—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti…KLS-Martin L.P.20260—
+5K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+5K260761APTUS Clavicle System 2.8Medartis AG20260—
+5K254215Arthrex Beaming SystemArthrex, Inc.20261—
+5K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+5K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+5K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+5K250865KLS Martin IPS Forearm SystemKLS-Martin L.P.20250—
+5K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+5K243368Montblanc Plate SystemMedifield Medical Co., Ltd.20250—
+5K250920Arthrex Spine Compression FT ScrewArthrex, Inc.20251—
+5K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20251—
+5K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K241695Extremity All Suture SystemField Orthopaedics20240—
+5K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K241018KLS Martin Orthopedic Implants - MR ConditionalKLS-Martin L.P.20241—
+5K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+5K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237—
+5K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+5K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+5K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+5K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+5K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+5K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+5K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+5K210994Arthrex Beveled FT ScrewsArthrex, Inc.20210—
+5K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K201962Skeletal Dynamics Ulnar Shortening Plating SystemSkeletal Dynamics, Inc.20200—
+5K201656ARIX Elbow SystemJeil Medical Corporation20200—
+5K192417ARIX Cannulated Screw SystemJeil Medical Corporation20191—
+5K191028KLS Martin Individual Patient SolutionsKLS-Martin L.P.20197—
+5K192297APTUS Wrist Arthrodesis PlatesMedartis AG20197—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+5K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K173746Activmotion RangeNewclip Technics20181—
+5K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+5K172008ARIX Humerus SystemJeil Medical Corporation20173—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K170705ARIX Wrist SystemJeil Medical Corporation20172—
+5K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+5K171152Stryker Universal Neuro III System AXS ScrewStryker20171—
+5K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+5K161746ARIX Hand SystemJeil Medical Corporation20161—
+5K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+5K153034aap LOQTEQ VA Radius Set 2.5Aap Implantate AG20160—
+5K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+5K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+5K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+5K140309CranioplugOssdsign AB20142—
+5K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+5K141489Linos Moh Hand Plating SystemKLS Martin L.P.20143—
+5K141677Variax Elbow Plating SystemStryker Trauma AG20140—
+5K141383Acumed Hand Fracture SystemAcumed, LLC20146—
+5K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+5K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+5K140769Variax 2 SystemStryker Trauma AG201419—
+5K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+5K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+5K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+5K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+5K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+5K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+5K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+5K112560Aptus (R) Distal Humerus SystemMedartis AG20118—
+5K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761—
+5K050868MaxlockOrthohelix Surgical Designs, Inc.2005343—
+6K262975Arthrex Beaming SystemArthrex, Inc.20260—
+6K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+6K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—