510(k) Report

Devices descending from K934429

538 later devices reach Anterior Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K193219G Surgical Marksman SystemG Surgical, LLC20191—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+6K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K171321K2M Navigation InstrumentsK2m201711
+6K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+6K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+6K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+6K153404Zavation Spinal SystemZavation, LLC20161—
+6K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+6K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+6K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+6K141850Flospine Pedicle Screw SystemFlospine20140—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+6K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201188—
+6K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+6K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+6K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+7K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+7K252322SIros-X SystemGenesys Spine20250—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—