510(k) Report

Devices descending from K093629

143 later devices reach Solitaire and Solitaire Peek Anterior Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+2K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+2K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+2K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+3K240715Idys® C ZP 3DTiClariance20240—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K212562Idys-C ZP 3DTiClariance, SA20211—
+3K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+3K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+3K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+3K152622Alta ACDF SystemBiomet Spine20160—
+3K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K242303MOD-COrthomod, LLC20260—
+4K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+4K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+5K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+5K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+5K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+5K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K230026SqualeImplanet, S.A.20230—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K221578Hexanium ACIFSpinevision, S.A.S.20224—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+5K211306LabyrinthZavation Medical Products, LLC20213—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+6K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+6K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+6K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+6K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+6K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K221172FOCUS Interbody SystemOc Medical Devices20220—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—