510(k) Report

Devices descending from K051296

836 later devices reach Sijf Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+6K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+6K241539Activmotion SNewclip Technics20240—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+6K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+6K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+6K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+6K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+6K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+6K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K230204ALPHALOK Plating SystemVilex, LLC20230—
+6K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+6K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+6K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+6K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+6K221558ALPHALOK Plating SystemVilex, LLC20222—
+6K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+6K221395Footmotion Plating SystemNewclip Technics20220—
+6K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+6K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+6K213214Xpert WristNewclip Technics20210—
+6K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K203381Dynanail Mini HybridMedShape, Inc.202141
+6K202810AutoStrut G2Orthospin, Ltd.20213—
+6K203138FIREBIRD SI Fusion SystemOrthofix, Inc.202025—
+6K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+6K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+6K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+6K200226RetroFixRetrofix Screws, LLC20200—
+6K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+6K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+6K193366T2 ICFStryker GmbH20201—
+6K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+6K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+6K190830TDM Screw SystemsTdm Co., Ltd.20191—
+6K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+6K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K173641Activ AnkleNewclip Technics20183—
+6K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+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—
+6K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+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—
+6K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+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—
+6K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261511Xpert AnkleNewclip Technics20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260761APTUS Clavicle System 2.8Medartis AG20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+7K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—