510(k) Report

Devices descending from K990776

368 later devices reach Aap Cannulated Screw, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+7K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+7K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+7K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+7K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+7K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+7K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+7K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+7K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+7K203595DynaFuse Fixation SystemMedShape, Inc.20225—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+7K202326BESPA Charcot SystemBespa Global, LLC20210—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K210159IntraLock SystemFusion Orthopedics, LLC20210—
+7K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+7K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+7K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS…Medartis AG202061
+7K193029Conquest FNSmith & Nephew, Inc.202010—
+7K192592Axis Plating SystemExtremity Medical, LLC20190—
+7K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+7K172785Conquest FNSmith & Nephew20178—
+7K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+7K152686Conquest FNSmith & Nephew201612—
+7K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+7K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+7K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+7K133525Locking Compression Bone Plates and Screw SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+7K133460Aptus Cannulated Compression ScrewsMedartis AG20138—
+7K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+7K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+7K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+7K124027Monster Screw SystemApogee Orthosolutions201341—
+7K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+7K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+7K102528N-Force Fixation SystemInnovision, Inc.20115—
+7K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+7K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+7K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+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—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+8K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+8K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+8K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+8K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+8K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.20220—
+8K213614Cannulated ScrewsMaxxion Medical, LLC20220—
+8K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—