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
+7K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+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—
+7K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+7K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K213417Ghost Spacer SystemLife Spine, Inc.20220—
+7K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+7K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+7K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+7K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+7K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+7K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K171651Excelsius GPSGlobus Medical, Inc.2017691
+7K152174Sniper Spine SystemSpine Wave, Inc.20158—
+7K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+7K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+7K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+7K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+7K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+7K123373Nautilus Spinal SystemLife Spine201317—
+7K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+7K111953Nautilus Spinal SystemLife Spine20123—
+7K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+7K090320Conquest Spinal SystemLife Spine20092—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252322SIros-X SystemGenesys Spine20250—
+8K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K241525ExcelsiusXR™Globus Medical, Inc.20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+8K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K240160EGPS Navigated InstrumentsAstura Medical20240—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—