510(k) Report

Devices descending from K031302

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+10K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+10K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+10K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+10K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+10K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+10K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+10K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+10K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+10K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+10K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+10K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+10K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+10K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+10K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+10K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+10K192993Scarlet AL-TSpineart20201—
+10K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+10K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+10K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+10K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+10K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+10K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+10K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+10K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+10K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+10K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+10K181397DualXInnovasive, Inc.201815—
+10K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+10K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+10K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+10K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+10K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+10K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+10K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+10K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+10K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+10K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+11K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+11K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+11K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+11K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+11K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+11K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+11K243474MagnetOs MISKuros Biosciences B.V20250—
+11K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+11K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+11K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+11K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+11K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+11K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+11K240453ReBOSSISOrthorebirth Co., Ltd.202402
+11K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+11K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+11K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+11K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+11K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+11K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+11K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+11K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+11K211740DualXAmplify Surgical, Inc.20211—
+11K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+11K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+11K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+11K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+11K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+11K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+11K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+11K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+11K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+11K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+11K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+11K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+11K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+11K171425Concorde LiftMedos International SARL201782
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+12K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+12K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+12K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+12K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+12K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+12K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+12K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+12K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+12K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+12K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+12K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+12K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+12K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+12K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+12K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+12K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+12K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—