510(k) Report

Devices descending from K032945

248 later devices reach Simplex X through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+7K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+7K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K252458Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd.20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+8K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+8K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+9K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+9K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+10K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+10K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+10K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+10K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—