510(k) Report

Devices descending from K033926

763 later devices reach Hourglass Vertebral Body Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+7K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+7K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+7K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+7K183064TxTi IBF SystemInnovasis, Inc.2019481
+7K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+7K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+7K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+7K183092Kuros TLIF CageKuros Biosciences B.V20190—
+7K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+7K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+7K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+7K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+7K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+7K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+7K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+7K172941CASCADIA Interbody SystemK2m201852—
+7K172009Cascadia Interbody SystemK2m, Inc.2017433
+7K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+7K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+7K171704CAPRI Corpectomy Cage SystemK2m201710—
+7K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+8K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+8K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+8K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+8K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+8K261067BEE PLIF CageNGMedical GmbH20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+8K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+8K250769Dakota LP SystemPrecision Spine, Inc.20250—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+8K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+8K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+8K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K223251Hexanium PLIFSpinevision, S.A.S.20220—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K221578Hexanium ACIFSpinevision, S.A.S.20224—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+8K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+8K211413BEE PLIF CageNGMedical GmbH20211—
+8K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+8K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—