510(k) Report

Devices descending from K160879

106 later devices reach CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+1K231479TriALTIS Spine SystemMedos International SARL20238—
+1K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+1K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+1K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+1K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+1K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+1K173095VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with…Medos International SARL201719—
+1K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL201748—
+2K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+2K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+2K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+2K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+2K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+2K253249TriALTIS™ Spine SystemMedos International SARL20251—
+2K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+2K243249TriALTIS™ Spine SystemMedos International SARL20250—
+2K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+2K233684TriALTIS™ Spine SystemMedos International SARL20234—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K231658VEOS Spinal Fixation SystemSpineway20230—
+2K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+2K223273ASTRA Spine SystemSpinecraft, LLC20228—
+2K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+2K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+2K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+2K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+2K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+2K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+2K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+2K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+2K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+2K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+2K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+2K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+2K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+2K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+2K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+2K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+2K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+2K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K171570Additional VIPER PRIME™ screws with fenestrationsMedos International SARL201720—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+3K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+3K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+3K243693NEO Pedicle Screw System™Neo Medical SA20240—
+3K242042TriALTIS™ Spine SystemMedos International SARL20241—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+3K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+3K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+4K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K222789VADER® Pedicle System, G21 CementIcotec AG202352