510(k) Report

Devices descending from K000080

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+6K190830TDM Screw SystemsTdm Co., Ltd.20191—
+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—
+6K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+6K172886Breakaway Screw SystemParagon 2820174—
+6K172350AxSOS 3 TiStryker GmbH201717—
+6K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+6K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+6K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+6K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc.20179—
+6K170843Alians Fragment SpecificNewclip Technics20171—
+6K170771VariAx 2 Foot SystemStryker GmbH20170—
+6K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+6K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation20170—
+6K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+6K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+6K152622Alta ACDF SystemBiomet Spine20160—
+6K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+6K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+6K151769Anchorage 2 CP SystemStryker GmbH20150—
+6K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4Orthofix Srl201519—
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260761APTUS Clavicle System 2.8Medartis AG20260—
+7K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+7K242303MOD-COrthomod, LLC20260—
+7K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+7K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+7K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+7K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+7K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K231860TDM Screw SystemTdm Co., Ltd.20240—
+7K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+7K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+7K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K232324StealthFix Intraosseous Fixation SystemMedartis, Inc.20230—
+7K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K231922DEPUY SYNTHES MAXFRAME AUTOSTRUT SystemDePuy Synthes20231—
+7K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K230329F3D Interbody SystemCorelink, LLC20230—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+7K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+7K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+7K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+7K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+7K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+7K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+7K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+7K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+7K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K191009Arsenal Plating SystemTrilliant Surgical20192—
+7K181630Revolution External Plating SystemNew Standard Device Dba Metalogix201915
+7K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+7K181091AxSOS 3 TiStryker GmbH201811—
+7K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+7K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+7K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801