510(k) Report

Devices descending from P000028

1,287 later devices reach Affinity (TM) Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+5K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+5K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+5K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+5K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+5K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+5K222833Ventana™ C Spinal SystemSpinal Elements, Inc.20234—
+5K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+5K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+5K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+5K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+5K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K223326Axiom PSR SystemRestor3D202301
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+5K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+5K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+5K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K212612Omnia Medical TiBrid-SCOmnia Medical, LLC20220—
+5K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+5K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K221172FOCUS Interbody SystemOc Medical Devices20220—
+5K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+5K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K222561AlignAcuity Surgical Devices, LLC202214—
+5K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+5K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+5K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+5K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+5K220610SOLO-LAurora Spine, Inc.20220—
+5K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+5K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+5K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+5K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+5K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+5K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+5K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+5K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+5K201793EDEN Peek CageJmt Co., Ltd.20210—
+5K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+5K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+5K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+5K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+5K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+5K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+5K200919Idys ALIF 3DTiClariance20210—
+5K202032Idys LLIF 3DTiClariance, Sas20210—
+5K210359Hexanium TLIFSpinevision, S.A.S.20211—
+5K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+5K202380Born PT-LIF Cage HASpineworxx AG20210—
+5K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+5K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+5K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K201087CORBEL SpacersGlobus Medical, Inc.202036—
+5K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+5K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+5K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+5K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+5K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+5K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+5K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+5K191796Neo Cage SystemNeo Medical SA20190—
+5K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+5K191134IB3D AlifMedicrea International SA20191—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K183407Triton CageMedyssey USA, Inc.20190—