510(k) Report

Devices descending from K080411

764 later devices reach Plateau Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232347MagnetOs GranulesKuros Biosciences B.V20242—
+7K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+7K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+7K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+7K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+7K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+7K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+7K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.20230—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K232315Catalyst Bone Void FillerOssdsign AB20237—
+7K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+7K230329F3D Interbody SystemCorelink, LLC20230—
+7K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+7K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223326Axiom PSR SystemRestor3D202301
+7K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+7K223251Hexanium PLIFSpinevision, S.A.S.20220—
+7K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K221172FOCUS Interbody SystemOc Medical Devices20220—
+7K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+7K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+7K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+7K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+7K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+7K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+7K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+7K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+7K203003Pantheon IBFDPantheon Spinal20210—
+7K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+7K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+7K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+7K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K200316UNiD IB3D ALIFMedicrea International SA20200—
+7K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+7K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+7K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+7K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+7K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+7K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+7K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+7K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+7K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+7K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+7K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K183407Triton CageMedyssey USA, Inc.20190—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K190680Favo S-TlifSilony Medical GmbH20190—
+7K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+7K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+7K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+7K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+7K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+7K182349Concorde LiftMedos International SARL20190—
+7K183092Kuros TLIF CageKuros Biosciences B.V20190—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+7K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+7K173537Concorde Lift™Medos International SARL20181—
+7K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+7K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+7K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+7K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+7K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+7K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+7K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—