510(k) Report

Devices descending from K072120

1,405 later devices reach Paramount Intervertebral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+6K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+6K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K213115CHENA-C Spacer SystemKahtnu Surgical, Inc.20210—
+6K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+6K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+6K212562Idys-C ZP 3DTiClariance, SA20211—
+6K211740DualXAmplify Surgical, Inc.20211—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+6K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+6K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K203444BEE HA CageNGMedical GmbH20211—
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+6K203207Omnia Medical TiBrid-SAOmnia Medical, LLC202012
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+6K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+6K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+6K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+6K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+6K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+6K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+6K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+6K193258ProLift Expandable SystemLife Spine, Inc.20203—
+6K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K190721LongBow TiLife Spine, Inc.20190—
+6K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+6K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+6K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+6K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+6K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+6K182608Oyster ACIF CageSilony Medical GmbH20190—
+6K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+6K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+6K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+6K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+6K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+6K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+6K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+6K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+6K180909REVEL SpacersGlobus Medical, Inc.201837—
+6K182584Lucent® XPSpinal Elements, Inc.20183—
+6K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+6K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+6K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+6K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+6K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+6K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+6K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+6K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+6K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+6K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+6K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+6K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+6K172065Scarlet AC-TSpineart20172—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K171519FLXfit™Expanding Orthopedics, Inc.2017711
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+6K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+6K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+6K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K162262Tritanium® PL CageStryker2016132—