510(k) Report

Devices descending from K051296

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+5K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+5K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200367Distal Humerus Plating SystemSkeletal Dynamics, Inc.20201—
+5K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+5K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+5K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand…Nebula Surgical Private Limited20193—
+5K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+5K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K191636APTUS Foot SystemMedartis AG20190—
+5K190722TriMAX Implant SystemCrossroads Extemity Systems, LLC20190—
+5K191241AutoStrutOrthospin20194—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K190230iFuse Implant System®SI-BONE, Inc.201957—
+5K182677DynaNail MiniMedShape, Inc.20195—
+5K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+5K182989AURORA™ Screw SystemMiRus, LLC20180—
+5K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLC20188—
+5K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+5K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+5K173883External Fixation SystemLife Spine, Inc.20180—
+5K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+5K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+5K173746Activmotion RangeNewclip Technics20181—
+5K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+5K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K172383Arthrosurface Bone ScrewsArthrosurface, Inc.20171—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+5K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+5K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+5K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+5K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws…Synthes USA Products, LLC201733—
+5K163440Stealth Staple SystemFirst Ray, LLC20173—
+5K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K153374CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of…Orthocare20161—
+5K153379AxSOS 3TiStryker GmbH201625—
+5K153638Bicortical Fixation Screw & Washer Nut SystemFirst Ray, LLC20160—
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K150561NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of…Narang Medical Limited20151—
+5K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.20151—
+5K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+5K151057WASTON Metallic Bone Plate and Screw SystemsChangzhou Waston Medical Appliance Co., Ltd.20150—
+5K150871ForeFoot STP SystemTornier, Inc.20150—
+5K150981SMV Scientific Bone ScrewsSmv Scientific20156—
+5K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20152—
+5K143702Arthrex Blunt Tip Screws with Fiber TapeArthrex, Inc.20154—
+5K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+5K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+5K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl201426—
+5K141992Variax 2 SystemStryker Trauma AG201422—
+5K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+5K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+5K122489Emerge Medical Solid Bone ScrewsEmerge Medical20121—
+6K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261191Alians Elbow SNewclip Technics20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+6K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+6K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+6K242303MOD-COrthomod, LLC20260—
+6K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+6K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+6K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+6K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+6K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+6K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+6K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—