510(k) Report

Devices descending from K123270

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+1K153587Taps for Resorbable ScrewsSynthes (USA) Products, LLC20170—
+1K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+1K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+2K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+2K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+2K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+2K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+2K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+2K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+2K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+2K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+2K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+2K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+2K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+2K223511Excella Navigation InstrumentsInnovasis, Inc.20233—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+2K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+2K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC20220—
+2K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+2K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K203816DeGen Navigated InstrumentationDegen Medical20211—
+2K202956Erisma LP Navigated InstrumentsClariance, Sas20210—
+2K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+2K203291CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc.202035—
+2K202771CD Horizon Spinal SystemMedtronic202021—
+2K200845Navigation Module of the Momentum SystemUlrich Medical USA20200—
+2K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+2K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+2K200791Navigation Enabled IntrumentsMedos International SARL20205—
+2K200095Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.202004
+2K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+2K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+2K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+2K181606Precision Spine Navigation InstrumentationPrecision Spine, Inc.20193—
+2K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+2K183381Navigation Enabled InstrumentsStryker20191—
+2K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+2K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionMedtronic Sofamor Danek USA, Inc.201841—
+2K172517SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2018601
+2K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+2K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+2K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+2K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+2K153603Alphatec Navigation InstrumentsAlphatec Spine, Inc.201679—
+2K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+2K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+2K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K143628Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc.2015206—
+3K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+3K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K252322SIros-X SystemGenesys Spine20250—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K252437JAZZ Spinal SystemImplanet20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+3K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+3K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+3K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+3K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+3K233256Robotic Integration InstrumentsDePuy Synthes20240—
+3K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K240963Spinal SystemTeslake, Inc.20240—
+3K240392JAZZ Spinal SystemImplanet20241—
+3K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+3K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+3K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+3K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—