510(k) Report

Devices descending from K171140

145 later devices reach Matrixx System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+1K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+1K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+1K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+1K210359Hexanium TLIFSpinevision, S.A.S.20211—
+1K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+1K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+1K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+1K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+1K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+1K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+1K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+1K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+1K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+2K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+2K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+2K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+2K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+2K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+2K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+2K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+2K223251Hexanium PLIFSpinevision, S.A.S.20220—
+2K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+2K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+2K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+2K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+2K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+2K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+3K240699SCARLET® AC-TiSpineart SA20240—
+3K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+3K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+3K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+3K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+3K221578Hexanium ACIFSpinevision, S.A.S.20224—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+3K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+3K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+3K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K223418DeGen Impulse AM™ SystemDegen Medical20236—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K212358Romero Cervical CageSpineup, Inc.20226—
+4K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—