510(k) Report

Devices descending from K072991

647 later devices reach Patriot Spacers: Colonial Acdf through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+4K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+4K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+4K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K223418DeGen Impulse AM™ SystemDegen Medical20236—
+4K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+4K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+4K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K223251Hexanium PLIFSpinevision, S.A.S.20220—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+4K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+4K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+4K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+4K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+4K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+4K210573Velofix SA Cervical CageU&I Corporation20211—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+4K203003Pantheon IBFDPantheon Spinal20210—
+4K211306LabyrinthZavation Medical Products, LLC20213—
+4K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+4K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+4K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+4K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K202637F3D Corpectomy SystemCorelink, LLC20201—
+4K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+4K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+4K201087CORBEL SpacersGlobus Medical, Inc.202036—
+4K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+4K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K192906Mecta-C Stand AloneMedacta International S.A.20201—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K190655SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201974—
+4K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181471ACCUFUSE Cervical SystemAbsolute Advantage Medical, LLC20180—
+4K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+4K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+4K172065Scarlet AC-TSpineart20172—
+4K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+4K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+4K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+4K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+4K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+4K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+4K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+4K143685Hedgehog Cervical Interbody Fusion DeviceVertera, Inc.201523—
+4K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+4K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—