510(k) Report

Devices descending from K051659

790 later devices reach Semial Spinal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+9K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+9K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+9K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+9K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+9K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+9K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+9K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+9K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+9K171425Concorde LiftMedos International SARL201782
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+10K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252322SIros-X SystemGenesys Spine20250—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+10K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+10K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+10K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+10K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+10K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+10K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+10K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+10K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+10K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+10K212358Romero Cervical CageSpineup, Inc.20226—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+10K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+10K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+10K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+10K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+10K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+10K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+10K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+10K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+10K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+10K182349Concorde LiftMedos International SARL20190—
+10K173537Concorde Lift™Medos International SARL20181—
+11K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+11K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+11K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+11K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+11K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+11K230026SqualeImplanet, S.A.20230—
+11K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+11K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+11K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+11K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+11K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+11K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+12K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+12K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+12K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+13K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—