510(k) Report

Devices descending from K043565

834 later devices reach Modification to Dynesys Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+6K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+6K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+6K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+6K210637CD Horizon™ Spinal SystemMedtronic202134—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+6K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K202771CD Horizon Spinal SystemMedtronic202021—
+6K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+6K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—
+6K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+6K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+6K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+6K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+6K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+6K183381Navigation Enabled InstrumentsStryker20191—
+6K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+6K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+6K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+6K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+6K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+6K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+6K173249CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20181—
+6K172469TiLock Modular Spinal SystemGenesys Spine20170—
+6K171321K2M Navigation InstrumentsK2m201711
+6K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+6K170347CD HORIZON™ Fenestrated Screw SetMedtronic Sofamor Danek USA201791—
+6K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+6K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K161379ELSA SpacersGlobus Medical, Inc.2016155—
+6K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+6K161627PASS LP Spinal SystemMedicrea International SA20167—
+6K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+6K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+6K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated2016159—
+6K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+6K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+6K152457CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2015145—
+6K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+6K150178CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201525—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+6K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+6K142591CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.2014212—
+6K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416—
+6K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc.2014286—
+6K141147Range Spinal SystemK2m, Inc.20141—
+6K140529Everest Spinal SystemK2m, LLC201431—
+6K140010Fortress Pedicle Screw SystemSpineology, Inc.201411—
+6K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+6K132866Nautilus Spinal SystemLife Spine, Inc.201315—
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+6K131343Reform Pedicle Screw SystemSpinal USA201331—
+6K130279Reform Pedicle Screw SystemSpinal USA201331—
+6K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+6K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+6K131030Range Spinal SystemK2m, Inc.201334—
+6K122877Range Spinal System, Small StatureK2m, Inc.201334—
+6K130330Range Spinal SystemK2m, Inc.201336—
+6K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+6K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+6K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+6K123809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20136—
+6K122592Instinct Java SystemZimmer Spine201301
+6K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—