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
+7K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+7K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+7K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+7K242303MOD-COrthomod, LLC20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+7K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+7K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+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—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+7K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+7K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+7K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+7K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+7K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+7K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+7K241539Activmotion SNewclip Technics20240—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed Medikal20240—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+7K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+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—
+7K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+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—
+7K230867Bone Bolt SystemUniversity of Utah, Department of Orthopaedics20230—
+7K230329F3D Interbody SystemCorelink, LLC20230—
+7K230204ALPHALOK Plating SystemVilex, LLC20230—
+7K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+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—
+7K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K221558ALPHALOK Plating SystemVilex, LLC20222—
+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—
+7K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.20221—
+7K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.20220—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213—
+7K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+7K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K203381Dynanail Mini HybridMedShape, Inc.202141
+7K202810AutoStrut G2Orthospin, Ltd.20213—
+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—
+7K201677Arthrex Mesh PlatesArthrex, Inc.20202—
+7K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.20206—
+7K201527EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)Smith & Nephew, Inc.20208—
+7K200226RetroFixRetrofix Screws, LLC20200—
+7K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K193366T2 ICFStryker GmbH20201—
+7K192619Pitkar Locked Plating SystemS.H.Pitkar Orthotools Pvt., Ltd.20200—
+7K192096Omnia Medical Trauma ScrewsOmnia Medical, LLC20200—
+7K190830TDM Screw SystemsTdm Co., Ltd.20191—
+7K190253EVOS Small Fragment Upper Extremity Plates Line AdditionsSmith & Nephew, Inc.20199—
+7K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+7K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+7K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+7K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+7K172886Breakaway Screw SystemParagon 2820174—
+7K172350AxSOS 3 TiStryker GmbH201717—
+7K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+7K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—