510(k) Report

Devices descending from K013962

900 later devices reach Equation Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+6K120928Synthes Matrix SystemSynthes Spine20120—
+6K121020Viper SystemDepuy Spine, Inc.201294—
+6K120696Tiger Spine SystemCorelink, LLC201241—
+6K101971Syntec OS Spinal Fixation SystemSyntec Scientific Corp.20110—
+6K092325Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20093—
+6K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007150—
+6K062606CD Horizon Spinal SystemMedtronic Sofamor Danek20062—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+7K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+7K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+7K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+7K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+7K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+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—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+7K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+7K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+7K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+7K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+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—
+7K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+7K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+7K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+7K201737Posterior Spinal Fixation SystemShanghai Reach Medical Instrument Co, Ltd.20211—
+7K211323ASTRA Spine SystemSpinecraft, LLC202112—
+7K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+7K210306GII Spinal Fixation SystemColigne AG20210—
+7K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+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—
+7K203816DeGen Navigated InstrumentationDegen Medical20211—
+7K210472SPINEART Navigation Instrument SystemSpineart20215—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+7K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+7K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K201648Sterispine™ PSSafe Orthopaedics202011
+7K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+7K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+7K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+7K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+7K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+7K183091Elaris Pedicle Screw SystemSpinewelding AG20190—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K190376PASS LP Spinal SystemMedicrea International SA201915
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—