510(k) Report

Devices descending from K024060

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+6K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company20221—
+6K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+6K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG20228—
+6K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+6K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+6K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+6K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+6K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+6K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+6K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+6K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212594OSSIOfiber® StapleOSSIO, Ltd.20222—
+6K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K212552Correx SoftwareVilex, LLC20210—
+6K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K211435PAO Cortical ScrewMedacta International S.A.20210—
+6K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+6K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+6K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+6K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+6K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+6K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+6K202307Activ FuseNewclip Technics20200—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+6K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+6K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+6K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+6K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+6K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+6K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+6K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+6K191636APTUS Foot SystemMedartis AG20190—
+6K191241AutoStrutOrthospin20194—
+6K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K190230iFuse Implant System®SI-BONE, Inc.201957—
+6K182677DynaNail MiniMedShape, Inc.20195—
+6K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+6K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+6K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+6K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+6K173883External Fixation SystemLife Spine, Inc.20180—
+6K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+6K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+6K173746Activmotion RangeNewclip Technics20181—
+6K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+6K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+6K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+6K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+6K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+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—
+6K163440Stealth Staple SystemFirst Ray, LLC20173—
+6K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+6K153379AxSOS 3TiStryker GmbH201625—
+6K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+6K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+6K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+6K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+6K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+6K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+6K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+6K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+6K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+6K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+6K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+6K141992Variax 2 SystemStryker Trauma AG201422—
+6K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+6K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+6K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+7K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+7K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261191Alians Elbow SNewclip Technics20260—