510(k) Report

Devices descending from K062085

95 later devices reach S4 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+1K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+1K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+1K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+1K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+1K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+1K090657Modification to: S4 Spinal SystemAesculap Implant Systems200994—
+2K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+2K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+2K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+2K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+2K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+2K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+2K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+2K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+2K180433Ennovate®Aesculap Implant Systems, LLC201811
+2K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+2K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+2K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+2K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+2K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+2K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+2K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+2K120838Synthes Matrix SystemSynthes Spine201216—
+2K120564Calypso SystemHogan Lovells US LLP201216—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+3K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+3K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+3K153404Zavation Spinal SystemZavation, LLC20161—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+3K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+3K141850Flospine Pedicle Screw SystemFlospine20140—
+3K132303Implanet Spine SystemImplanet, S.A.201315—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K240392JAZZ Spinal SystemImplanet20241—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+4K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+4K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+4K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+4K162764Jazz Frame SystemImplanet, S.A.20176—
+4K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K252437JAZZ Spinal SystemImplanet20250—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+5K232628VADER® Pedicle SystemIcotec AG20241—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+5K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+5K191217Jazz PFImplanet, S.A.20190—
+5K171881JAZZ Passer BandImplanet, S.A.20170—
+5K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—