510(k) Report

Devices descending from K060300

176 later devices reach Confidence High Viscosity Bone Cement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K221244CD Horizon™ Spinal SystemMedtronic202220—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+6K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+6K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+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—
+7K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+7K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+7K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+8K232628VADER® Pedicle SystemIcotec AG20241—
+8K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+8K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K210549ARx Spinal SystemLife Spine, Inc.20211—
+9K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+9K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+9K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+9K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—