510(k) Report

Devices descending from K033995

624 later devices reach 3.5 MM LCP Distal Humerus System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+6K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+6K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+6K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+6K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+6K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+6K202307Activ FuseNewclip Technics20200—
+6K203011Monster Screw SystemParagon 28, Inc.20206—
+6K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+6K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+6K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+6K191636APTUS Foot SystemMedartis AG20190—
+6K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+6K191241AutoStrutOrthospin20194—
+6K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+6K182677DynaNail MiniMedShape, Inc.20195—
+6K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+6K182989AURORA™ Screw SystemMiRus, LLC20180—
+6K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+6K181091AxSOS 3 TiStryker GmbH201811—
+6K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+6K173883External Fixation SystemLife Spine, Inc.20180—
+6K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+6K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+6K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+6K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+6K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+6K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+6K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+6K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+6K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+6K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+6K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+6K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+6K153378Monster BITE Screw SystemParagon 28201522—
+6K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+6K150871ForeFoot STP SystemTornier, Inc.20150—
+6K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+6K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+6K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+6K141992Variax 2 SystemStryker Trauma AG201422—
+6K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+6K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+7K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+7K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+7K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+7K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K251555Ultra™ Compression Screw SystemPace Surgical20251—
+7K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+7K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K241525ExcelsiusXR™Globus Medical, Inc.20250—
+7K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+7K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+7K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+7K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+7K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+7K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+7K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+7K240160EGPS Navigated InstrumentsAstura Medical20240—
+7K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+7K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+7K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+7K223558CUVIS-spineCurexo, Inc.20230—
+7K230204ALPHALOK Plating SystemVilex, LLC20230—
+7K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+7K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+7K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+7K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+7K221558ALPHALOK Plating SystemVilex, LLC20222—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+7K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+7K211616ExcelsiusHubGlobus Medical, Inc.20219Class I