510(k) Report

Devices descending from K020522

1,234 later devices reach Modification to Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K212520ProLift Micro Expandable Spacer SystemLife Spine, Inc.20216—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+4K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+4K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+4K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+4K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+4K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K193174Keos Lumbar IBFDKeos20190—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K190721LongBow TiLife Spine, Inc.20190—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+4K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+4K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+4K181899Roccia® PlifSilony Medical GmbH20180—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K181531SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20183—
+4K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+4K181397DualXInnovasive, Inc.201815—
+4K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+4K173893TrabisColigne AG20180—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K172480icotec Interbody Cage SystemIcotec AG20185—
+4K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+4K172568CervagePrecifit Medical, Ltd.20181—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K173128Alamo® CAlliance Partners, LLC20182—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+4K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+4K172009Cascadia Interbody SystemK2m, Inc.2017433
+4K172020Arlington PLIF/TLIF CageSignature Orthopaedics Pty, Ltd.20170—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K172424Velofix™ SA Cervical CageU&I Corporation201751
+4K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.201746—
+4K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+4K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+4K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+4K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+4K171519FLXfit™Expanding Orthopedics, Inc.2017711
+4K171704CAPRI Corpectomy Cage SystemK2m201710—
+4K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+4K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+4K170055CAPRI Corpectomy Cage SystemK2m201711—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+4K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+4K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+4K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+4K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+4K163180Hubble IIOrbbo Surgical, LLC20160—
+4K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+4K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+4K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+4K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+4K153786Prow Fusion-VNlt Spine, Ltd.20166—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K160995NEOVIEW Plating SystemIn2bones Sas201624
+4K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—
+4K160125Cascadia Interbody SystemK2m2016315—
+4K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+4K160547Cascadia Interbody SystemK2m2016157—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—