510(k) Report

Devices descending from K961192

479 later devices reach Irrigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.20240—
+7K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+7K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+7K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+7K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+7K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+7K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+7K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+7K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+7K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+7K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+7K223511Excella Navigation InstrumentsInnovasis, Inc.20233—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K223494CD Horizon Spinal SystemMedtronic202317—
+7K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+7K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+7K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+7K221244CD Horizon™ Spinal SystemMedtronic202220—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC20220—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+7K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+7K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+7K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+7K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+7K203816DeGen Navigated InstrumentationDegen Medical20211—
+7K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+7K202956Erisma LP Navigated InstrumentsClariance, Sas20210—
+7K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+7K203291CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc.202035—
+7K202771CD Horizon Spinal SystemMedtronic202021—
+7K200845Navigation Module of the Momentum SystemUlrich Medical USA20200—
+7K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+7K200791Navigation Enabled IntrumentsMedos International SARL20205—
+7K200095Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.202004
+7K200841Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11Ethicon Endo-Surgery, LLC20204—
+7K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+7K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+7K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+7K181606Precision Spine Navigation InstrumentationPrecision Spine, Inc.20193—
+7K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+7K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+7K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+7K183381Navigation Enabled InstrumentsStryker20191—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+7K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionMedtronic Sofamor Danek USA, Inc.201841—
+7K181596Spine Wave Navigated InstrumentsSpine Wave, Inc.20181—
+7K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+7K172517SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2018601
+7K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+7K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K171267NavLock TrackersMedtronic Navigation201741
+7K162921Navigated Instrument SystemOrthofix, Inc.20175—
+7K163548ENSEAL X1 Large Jaw Tissue SealerEthicon Endo-Surgery, LLC20170—
+7K153587Taps for Resorbable ScrewsSynthes (USA) Products, LLC20170—
+7K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+7K153603Alphatec Navigation InstrumentsAlphatec Spine, Inc.201679—
+7K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+7K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+7K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+7K143628Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc.2015206—
+7K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+8K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC20260—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+8K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+8K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+8K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+8K252437JAZZ Spinal SystemImplanet20250—
+8K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+8K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521