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
+6K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+6K172065Scarlet AC-TSpineart20172—
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+6K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+6K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+6K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+6K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+6K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+6K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+6K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+6K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+6K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+6K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+6K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+6K170055CAPRI Corpectomy Cage SystemK2m201711—
+6K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+6K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+6K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K162264Cascadia Interbody SystemK2m, Inc.2016169—
+6K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+6K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+6K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+6K153621Juliet® TiSpineart2016751
+6K153786Prow Fusion-VNlt Spine, Ltd.20166—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+6K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+6K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+6K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+6K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+6K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+6K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+6K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+6K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+6K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+6K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+6K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+6K141798Sypher Spacer SystemBiogennix, LLC20151—
+6K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+6K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+6K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+6K132738Cogent Med-LifCogent Spine, LLC201413—
+6K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+6K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+6K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+6K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+6K122588Vusion CS PlusOrtho Development Corp.2013206—
+6K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+6K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+6K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+6K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+6K122021Sterispine LC CageSafe Orthopaedics20122—
+6K120576Zavation Ibf SystemZavation, LLC201232—
+7K263049SABER-C SystemElevation Spine20260—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K260660SABER-C SystemElevation Spine20261—
+7K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+7K253260ORIO-3D Cage SystemSpineCraft20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+7K250540SABER-C SystemElevation Spine20252—