510(k) Report

Devices descending from K040284

906 later devices reach Sustain Radiolucent Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+9K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+9K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+9K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+9K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+9K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+9K192993Scarlet AL-TSpineart20201—
+9K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+9K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+9K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+9K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+9K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+9K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+9K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+9K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+9K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+9K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+9K181397DualXInnovasive, Inc.201815—
+9K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+9K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+9K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+9K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+9K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+9K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+9K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+9K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+9K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+9K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+10K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+10K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+10K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+10K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+10K252322SIros-X SystemGenesys Spine20250—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K243474MagnetOs MISKuros Biosciences B.V20250—
+10K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+10K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+10K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+10K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+10K240453ReBOSSISOrthorebirth Co., Ltd.202402
+10K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+10K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+10K211740DualXAmplify Surgical, Inc.20211—
+10K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+10K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+10K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+10K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+10K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+10K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+10K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+10K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+10K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+10K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+10K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+10K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+10K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+10K171425Concorde LiftMedos International SARL201782
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+11K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+11K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+11K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+11K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+11K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+11K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+11K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+11K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+11K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+11K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+11K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+11K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+11K182349Concorde LiftMedos International SARL20190—
+11K173537Concorde Lift™Medos International SARL20181—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+12K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—