510(k) Report

Devices descending from K071824

103 later devices reach Acme Talon Pedicle Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182283FUSE Pedicle Screw SystemBlack Box Medical20180—
+1K181554Stowe Pedicle Screw SystemBlack Box Medical20181—
+1K122229Viceroy Spinal SystemTorrey Spine20120—
+1K120091R&D Innovation Pedicle Screw SystemR&D Innovation, LLC20121—
+1K102995Talon Spinal SystemSpine36020114—
+1K081331Fixxsure Cross LinkSpineworks, LLC200891—
+2K241494Pantheon Pedicle Screw and Iliac Bolt Fixation SystemPantheon Spinal20241—
+2K201751Pedicle Screw SystemBlack Box Medical, LLC20200—
+2K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+2K162143FixxSure® X-LinkInnovasis, Inc.20160—
+2K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+2K153152Syzygy Stabilization SystemAmendia, Inc.201602
+2K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201189—
+3K252219Cervical Interbody and VBR Fusion SystemSync Surgical20260—
+3K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201188—
+4K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+4K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+4K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+5K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+5K182721Choice Spine Navigation SystemChoicespine, LP20192—
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+5K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+5K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+5K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+6K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+6K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+6K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+6K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+6K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+6K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+7K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+9K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+10K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+10K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+10K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+10K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+10K232432E3D™-A Interbody SystemEvolution Spine20248—
+10K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+10K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+10K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+10K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+10K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+10K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+11K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+11K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+11K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+11K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+11K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+11K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+11K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+11K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+11K241846E3D™-C Interbody SystemEvolution Spine20246—
+11K240368E3D™-A Interbody SystemEvolution Spine20247—
+11K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+11K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+11K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+11K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+11K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+11K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+11K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+11K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+11K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+12K262094E3D™-C Interbody SystemEvolution Spine20260—
+12K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+12K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+12K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+12K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+12K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+12K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+12K260038E3D™-C Interbody SystemEvolution Spine20261—
+12K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+12K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+12K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+12K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+12K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+12K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+12K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+12K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+12K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—