510(k) Report

Devices descending from K100042

864 later devices reach Difusion Technologies Xiphos Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+1K151819Integrity Spine Lumbar Interbody Fusion SystemIntegrity Spine Lumbar Interbody Fusion System20154—
+1K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+1K123969XiphosDifusion Technologies201314—
+1K113138Aleutian SystemK2m, Inc.2012549—
+1K111512Bonebac T-Plif Intervertebral Body Fusion Device SystemThompson Mis, Inc.2011762—
+2K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+2K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K150481Cascadia Interbody SystemK2m, Inc.20154593
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+2K133614Aleutian Ibf SystemK2m, Inc.2014527—
+2K122588Vusion CS PlusOrtho Development Corp.2013206—
+2K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+2K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+2K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+2K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+3K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+3K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+3K172941CASCADIA Interbody SystemK2m201852—
+3K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+3K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+3K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+3K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+3K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+3K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+3K170055CAPRI Corpectomy Cage SystemK2m201711—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K163364MOJAVE Expandable Interbody SystemK2m201725—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K162264Cascadia Interbody SystemK2m, Inc.2016169—
+3K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+3K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+3K153621Juliet® TiSpineart2016751
+3K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+3K153786Prow Fusion-VNlt Spine, Ltd.20166—
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+3K160125Cascadia Interbody SystemK2m2016315—
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K160547Cascadia Interbody SystemK2m2016157—
+3K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+3K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+3K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+3K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+3K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+3K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+3K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K142487Chesapeake Stabilization SystemK2m, Inc.201571
+3K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+3K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+3K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+3K142277Juliet POSpineart2014119—
+3K140474Juliet OLSpineart2014120—
+3K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+3K123758Tasmin RSignus Medizintechnik GmbH20141—
+3K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+3K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+3K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+3K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+4K261049Scala® TLSpineart SA20260—
+4K261408SABER-XA SystemElevation Spine20260—
+4K2530413d Cage CervicalFims Co., Ltd.20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—