510(k) Report

Devices descending from K964024

700 later devices reach Depuy Motech Titanium Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K232628VADER® Pedicle SystemIcotec AG20241—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+6K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+6K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K211323ASTRA Spine SystemSpinecraft, LLC202112—
+6K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+6K210306GII Spinal Fixation SystemColigne AG20210—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+6K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+6K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+6K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+6K151813Sniper Spine SystemSpine Wave, Inc.20159—
+6K143110GALAXY MIS Screw SystemBm Korea20152—
+6K142360Everest Spinal SystemK2m, Inc.201522—
+6K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+6K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+6K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+6K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+6K123164Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.201336
+6K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+6K100122Modification to Capsure PS SystemSpine Wave, Inc.20102—
+6K083743Capsure PS SystemSpine Wave, Inc.20093—
+6K080767Conquest Spinal SystemLife Spine200821—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+7K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—