510(k) Report

Devices descending from K022778

670 later devices reach Modification to TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.201494—
+6K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176—
+6K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013243—
+6K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+6K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+6K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013195—
+6K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013244—
+6K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+6K122592Instinct Java SystemZimmer Spine201301
+6K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012211—
+6K122433CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.201239—
+6K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+6K120564Calypso SystemHogan Lovells US LLP201216—
+6K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012357—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+7K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+7K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+7K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+7K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+7K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+7K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+7K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+7K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+7K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+7K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+7K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+7K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+7K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+7K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202135—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K201648Sterispine™ PSSafe Orthopaedics202011
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+7K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+7K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+7K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+7K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K182928CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201953—
+7K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—