510(k) Report

Devices descending from K082874

168 later devices reach Biodrive Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+1K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+1K1431883.Omm Biomet Cannulated Screw SystemBiomet Manufacturing Corp201481
+1K140891Biomet Cannulated Screw SystemBiomet, Inc.2014165
+1K140018TSP Hip Fracture Plating SystemBiomet, Inc.201412
+1K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+2K254280F.A.S.T ScrewSteps Ortho20260—
+2K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+2K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+2K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+2K212979CalcShift™ Displacement Calcaneal Osteotomy SystemNextremity Solutions, Inc.20220—
+2K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbH20222—
+2K213301InCore Subtalar SystemNextremity Solutions, Inc.20210—
+2K193214WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…Biomet, Inc.20203—
+2K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+2K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+3K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+3K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+3K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+3K192592Axis Plating SystemExtremity Medical, LLC20190—
+3K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+3K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+3K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+3K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+4K240715Idys® C ZP 3DTiClariance20240—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+4K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+4K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+4K212562Idys-C ZP 3DTiClariance, SA20211—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+4K152622Alta ACDF SystemBiomet Spine20160—
+4K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K242303MOD-COrthomod, LLC20260—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K230329F3D Interbody SystemCorelink, LLC20230—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+5K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+5K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+5K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+5K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+5K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+5K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+5K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+5K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+6K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+6K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+6K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+6K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+6K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+6K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+6K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+6K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+6K230026SqualeImplanet, S.A.20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K221578Hexanium ACIFSpinevision, S.A.S.20224—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+7K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+7K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—