510(k) Report

Devices descending from K081177

848 later devices reach Blackstone Medical, Inc., Pillar Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+4K200312Tryptik TiSpineart20202—
+4K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K190721LongBow TiLife Spine, Inc.20190—
+4K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+4K1803473d CageFims Co., Ltd.20190—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+4K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181818Scarlet AL-TSpineart201864—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K163595IMPIX 3D Print CagesMedicrea International SA2017282
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+4K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+4K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+4K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+4K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+4K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+4K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+4K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+5K261430TruLift Expandable SystemLife Spine, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+5K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+5K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+5K250556Porous Biologic ScaffoldVentris Medical20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+5K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+5K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—