510(k) Report

Devices descending from K183705

99 later devices reach IdentiTi Porous Ti Interbody System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+1K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+1K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+1K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+1K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+1K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+1K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+1K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+1K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+1K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+1K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+1K201287Impulse Interbody Fusion SystemDegen Medical20208—
+1K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+1K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+1K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+1K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+2K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+2K260038E3D™-C Interbody SystemEvolution Spine20261—
+2K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+2K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+2K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+2K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+2K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+2K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+2K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+2K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+2K240368E3D™-A Interbody SystemEvolution Spine20247—
+2K232432E3D™-A Interbody SystemEvolution Spine20248—
+2K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+2K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+2K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+2K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+2K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+2K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+2K223418DeGen Impulse AM™ SystemDegen Medical20236—
+2K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+2K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+2K213417Ghost Spacer SystemLife Spine, Inc.20220—
+2K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+2K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+2K212358Romero Cervical CageSpineup, Inc.20226—
+2K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+2K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K262094E3D™-C Interbody SystemEvolution Spine20260—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+3K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+3K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+3K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+3K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+3K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+3K230026SqualeImplanet, S.A.20230—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+3K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+3K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+5K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+5K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—