510(k) Report

Devices descending from K041939

718 later devices reach Blackstone Peek Vertebral Body Replacement System Lordotic Lateral Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K202032Idys LLIF 3DTiClariance, Sas20210—
+5K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+5K202380Born PT-LIF Cage HASpineworxx AG20210—
+5K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+5K202488ZSFab Cervical Interbody SystemZsfab, Inc.20216—
+5K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+5K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+5K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+5K183259Idys™ TLIF TiVacClariance, Sas20191—
+5K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+5K182477Cervical SpacerAdditive Implants, LLC201915—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K182584Lucent® XPSpinal Elements, Inc.20183—
+5K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+5K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+5K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+5K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K171312FortiCore®Nanovis, LLC20183—
+5K173702Juliet Ti LLSpineart20182—
+5K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K172083Idys™ ALIF SystemClariance, Sas20177—
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+5K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+5K172065Scarlet AC-TSpineart20172—
+5K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017116—
+5K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+5K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+5K170055CAPRI Corpectomy Cage SystemK2m201711—
+5K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+5K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+5K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+5K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+5K162264Cascadia Interbody SystemK2m, Inc.2016169—
+5K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+5K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+5K153621Juliet® TiSpineart2016751
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+5K141798Sypher Spacer SystemBiogennix, LLC20151—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+5K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+5K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+5K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+5K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+5K122588Vusion CS PlusOrtho Development Corp.2013206—
+5K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+5K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+5K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+5K122366Tryptik CC Anterior Intersomatic Cervical CageSpineart20125—
+5K122021Sterispine LC CageSafe Orthopaedics20122—
+5K120576Zavation Ibf SystemZavation, LLC201232—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K251016MectaLIF 3D MetalMedacta International S.A.20250—
+6K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—