510(k) Report

Devices descending from K123270

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+3K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+3K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+3K231184CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20230—
+3K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+3K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+3K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+3K213918DeGen Navigated InstrumentationDegen Medical20220—
+3K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+3K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+3K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+3K211596CD Horizon Spinal SystemMedtronic20213—
+3K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+3K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+3K210306GII Spinal Fixation SystemColigne AG20210—
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+3K210472SPINEART Navigation Instrument SystemSpineart20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+3K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+3K201006K2M Navigation InstrumentsK2m, Inc.20200—
+3K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+3K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+3K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+3K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+3K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+3K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+3K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+3K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182721Choice Spine Navigation SystemChoicespine, LP20192—
+3K181596Spine Wave Navigated InstrumentsSpine Wave, Inc.20181—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+3K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+3K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+3K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+3K172115Navigated Instrument SystemOrthofix, Inc.20184—
+3K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+3K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K171321K2M Navigation InstrumentsK2m201711
+3K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+3K162921Navigated Instrument SystemOrthofix, Inc.20175—
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+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—
+4K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+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—
+4K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+4K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+4K252742Navigated InstrumentsTyber Medical, LLC20251—
+4K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+4K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+4K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+4K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+4K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K241895Cannulated PsiFGuardSpineguard20240—
+4K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+4K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+4K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—