510(k) Report

Devices descending from K032064

1,280 later devices reach Theken Cpod/Lpod Vertebral Body Replacement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+8K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+8K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K201006K2M Navigation InstrumentsK2m, Inc.20200—
+8K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+8K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+8K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+8K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+8K182584Lucent® XPSpinal Elements, Inc.20183—
+8K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+8K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+8K173153Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion SystemNu Vasive, Incorporated2017160—
+8K171425Concorde LiftMedos International SARL201782
+8K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+8K162262Tritanium® PL CageStryker2016132—
+8K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+8K160955Tritanium® PL CageStryker2016178—
+8K160715AccuLIF TL and PL CageStryker Corporation20160—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+9K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+9K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+9K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+9K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+9K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+9K234150Lucent® XPSpinal Elements20240—
+9K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+9K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+9K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+9K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+9K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+9K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+9K182349Concorde LiftMedos International SARL20190—
+9K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+9K181014Tritanium PL CageStryker Spine2018137—
+9K173537Concorde Lift™Medos International SARL20181—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+10K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+11K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+11K230989Rod Registration FrameNu Vasive, Incorporated20230—
+12K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—