510(k) Report

Devices descending from K111520

418 later devices reach Ipc Powerease System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+3K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.201941
+3K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+3K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions20194—
+3K182721Choice Spine Navigation SystemChoicespine, LP20192—
+3K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation201831
+3K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+3K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+3K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+3K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+3K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+3K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+3K171321K2M Navigation InstrumentsK2m201711
+3K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+3K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+4K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+4K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+4K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K252742Navigated InstrumentsTyber Medical, LLC20251—
+4K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+4K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+4K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+4K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+4K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment…Brainlab AG20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+4K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+4K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial…Brainlab AG20231—
+4K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+4K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+4K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+4K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+4K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+4K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+4K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+4K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+4K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+4K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+4K213454Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…Medtronic Powered Surgical Solutions20210—
+4K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG20212—
+4K212023Virage Navigation SystemZimmer Biomet Spine, Inc.20211—
+4K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+4K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+4K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—