510(k) Report

Devices descending from K123206

454 later devices reach Maxim Surgical X-Treme Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+5K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+5K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+5K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+5K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+5K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+5K222004INTEGRATE -C Interbody Fusion SystemHappe Spine20236—
+5K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K230583Tryptik TiSpineart SA20231—
+5K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+5K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+5K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+5K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+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—
+5K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+5K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+5K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+5K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+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—
+5K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K203444BEE HA CageNGMedical GmbH20211—
+5K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+5K210359Hexanium TLIFSpinevision, S.A.S.20211—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+5K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+5K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+5K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+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—
+5K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+5K200312Tryptik TiSpineart20202—
+5K192897icotec Cervical CageIcotec AG20201—
+5K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+5K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+5K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+5K191134IB3D AlifMedicrea International SA20191—
+5K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K190680Favo S-TlifSilony Medical GmbH20190—
+5K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+5K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+5K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+5K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+5K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+5K171704CAPRI Corpectomy Cage SystemK2m201710—
+5K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—