510(k) Report

Devices descending from K000080

916 later devices reach Asnis Iii Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210146Cannulated Compression Device SystemOrthopedic Designs North America, Inc.20220—
+1K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH20222—
+1K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+1K172596Large Screws RangeNewclip Technics20174—
+1K163627Shotel Ankle Arthrodesis Nail SystemBiopro, Inc.20170—
+1K171558ExsoMed ITN Cannulated Screw SystemExsomed Holdings Company, LLC20177—
+1K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A.201735—
+1K160617Large Screws RangeNewclip Technics20166—
+1K153759SIGN Compression Screw SystemSign Fracture Care International20160—
+1K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+1K133451Fixos Screw SystemStryker Trauma AG20143—
+1K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+1K092754Sbi Foot and Ankle Cannulated Screw System, Model 100-0061Small Bone Innovations, Inc.20104—
+1K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+1K082574Maxtorque Mini Cannulated Screw SystemOrthohelix Surgical Designs, Inc.200833
+1K071092Asnis Micro Cannulated ScrewHowmedica Osteonics Corp.200738—
+1K060736Smith & Nephew 6.5MM and 8.0MM Cannulated ScrewsSmith & Nephew, Inc.20065311
+1K060428CSS Cannulated Screw SystemOrthohelix Surgical Designs, Inc.2006464
+1K051296Sijf Cannulated Screw SystemDepuy Spine, Inc.2005836—
+1K043410Epiphysis ScrewI.T.S. Implantat-Technologie-Systeme GmbH200512—
+1K040265Little Grafter ScrewBiocomposites, Ltd.20041—
+2K262075Lapidus Screw KitRelja Innovations, LLC20260—
+2K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+2K250935TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System…TriMed, Inc.20250—
+2K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K223468Nexis® compressive screwsNovastep20230—
+2K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+2K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+2K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+2K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+2K193083M.U.S.T. Sacral Illiac Screw and Pelvic Trauma SystemMedacta International S.A.201921—
+2K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+2K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+2K190025EVOL® -SI Joint Fusion SystemCutting Edge Spine, LLC20196—
+2K183603INnate Cannulated Screw SystemExsomed Corporation20195—
+2K182989AURORA™ Screw SystemMiRus, LLC20180—
+2K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+2K173641Activ AnkleNewclip Technics20183—
+2K170012Foot and Hand MotionNewclip Technics20170—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+2K150871ForeFoot STP SystemTornier, Inc.20150—
+2K141401Easy OutFeet For Life Podiatry Center20150—
+2K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+2K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+2K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+2K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+2K130590Aap Cannulated Screw 2.0Aap Implantate AG20130—
+2K124027Monster Screw SystemApogee Orthosolutions201341—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292—
+2K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+2K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc.2011238—
+2K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+2K102528N-Force Fixation SystemInnovision, Inc.20115—
+2K110658Aptus Cannulated Compression ScrewsMedartis AG201112—
+2K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+2K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+2K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc.2010245—
+2K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+2K093676Omnitech Large, Trimed Compression ScrewTriMed, Inc.201013—
+2K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+2K082874Biodrive Cannulated Screw SystemBiomet Trauma2009168—
+2K080398SI Joint Fusion SystemSI-BONE, Inc.2008144—
+2K082949Orthopediatrics Bone ScrewsOrthoPediatrics Corp.200811—
+2K080649Pogo ScrewFxdevices200815—
+2K073312Osteotrans-OT ScrewTakiron Co., Ltd.20080—
+2K072818Peri-Loc Periartricular LCK Pit Sys-Prox Fem Plates/Screws.Calbe AccessSmith & Nephew, Inc.200793—
+3K261511Xpert AnkleNewclip Technics20260—
+3K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+3K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K243943TriMed® Compression ScrewsTriMed, Inc.20252—
+3K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+3K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+3K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC20231—
+3K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC20233—
+3K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+3K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+3K221342REDEMPTION Beaming SystemVilex, LLC20220—
+3K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+3K221395Footmotion Plating SystemNewclip Technics20220—