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
+8K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+8K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+8K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+8K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+8K223558CUVIS-spineCurexo, Inc.20230—
+8K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+8K230026SqualeImplanet, S.A.20230—
+8K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+8K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K201569CUVIS-spineCurexo, Inc.20212—
+8K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+8K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+8K200303Reform Pedicle Screw SystemPrecision Spine202010—
+8K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+8K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+8K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+8K190751Connector SystemOrthofix, Inc.20193—
+8K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+8K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+8K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+8K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+8K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+8K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+8K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+8K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+8K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+8K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+8K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K252437JAZZ Spinal SystemImplanet20250—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+9K240392JAZZ Spinal SystemImplanet20241—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+9K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+9K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+9K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+9K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+9K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+9K222698CUVIS-spineCurexo, Inc.20220—
+9K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+9K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+9K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+9K182182YUKON OCT Spinal SystemK2m20185—
+9K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+9K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+9K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+9K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+9K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+9K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+10K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+10K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+10K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+10K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+10K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+10K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+10K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+10K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+10K200896Solstice CCILife Spine, Inc.20200—
+10K193129Yukon OCT Spinal SystemK2m, Inc.202001
+10K183381Navigation Enabled InstrumentsStryker20191—
+10K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+10K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+10K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+11K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+11K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+11K182470Plateau Spacer SystemLife Spine20180—