510(k) Report

Devices descending from K033702

1,036 later devices reach Blackstone Peek Vertebral Body Replacement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180695FBC 921 (Alif)Fbc Device Aps20180—
+5K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+5K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+5K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K170235Lucent®Spinal Elements, Inc.2017107—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+5K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+5K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+5K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K163269Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic…Titan Spine, LLC2017143—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+5K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+5K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+5K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+5K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+5K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+5K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated201694—
+5K153665Prow Fusion-LNlt Spine, Ltd.20160—
+5K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+5K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+5K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+5K152622Alta ACDF SystemBiomet Spine20160—
+5K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+5K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+5K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+5K160125Cascadia Interbody SystemK2m2016315—
+5K160547Cascadia Interbody SystemK2m2016157—
+5K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+5K151481Sahara Stabilization SystemK2m, Inc.20155—
+5K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+5K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+5K150481Cascadia Interbody SystemK2m, Inc.20154593
+5K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+5K142487Chesapeake Stabilization SystemK2m, Inc.201571
+5K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+5K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+5K141135Juliet LLSpineart2014146—
+5K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+5K141942Midline II TICentinel Spine, Inc.2014459—
+5K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+5K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+5K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+5K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+5K133614Aleutian Ibf SystemK2m, Inc.2014527—
+5K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+5K133126K7 Lumbar SpacersK7, LLC20131—
+5K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+5K131178Idys Lif CagesClariance201311—
+5K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+5K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+5K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+5K130699Aleutian Spinal SystemK2m, Inc.2013570—
+5K123388K7C SpacerK7, LLC20130—
+5K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+5K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+5K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+5K113138Aleutian SystemK2m, Inc.2012549—
+5K112664Zavation Ibf SystemsZavation, LLC201137—
+5K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+5K103169AleuttianK2m, Inc.2011572—
+5K101302Aleutian Ibf SystemK2m, Inc.2010595—
+6K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+6K261049Scala® TLSpineart SA20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261430TruLift Expandable SystemLife Spine, Inc.20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+6K250560BEE HANGMedical GmbH20250—
+6K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—