510(k) Report

Devices descending from K955348

1,019 later devices reach Titanium Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K132361Everest Spinal SystemK2m, Inc.201334—
+5K132575Pass LP Spinal SystemMedicrea International20130—
+5K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+5K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K131343Reform Pedicle Screw SystemSpinal USA201331—
+5K130279Reform Pedicle Screw SystemSpinal USA201331—
+5K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+5K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+5K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+5K121728Tiger Spine SystemCorelink, LLC201250—
+5K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+5K121172Reform Pedicle Screw SystemSpinal USA201233—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+5K120564Calypso SystemHogan Lovells US LLP201216—
+5K120571Synthes Uss ConnectorSynthes Spine201274—
+5K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+5K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+5K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+5K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+5K110283Zenius Spinal SystemMedyssey Co, Ltd.201114—
+5K103272Zenius Spinal SystemMedyssey Co, Ltd.201015—
+5K100605Mis SystemSpine Wave, Inc.201033—
+5K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+5K090320Conquest Spinal SystemLife Spine20092—
+5K083353Capsure (R) PS SystemSpine Wave, Inc.200836—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+6K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+6K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K241525ExcelsiusXR™Globus Medical, Inc.20250—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+6K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+6K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240160EGPS Navigated InstrumentsAstura Medical20240—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+6K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+6K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+6K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+6K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K231658VEOS Spinal Fixation SystemSpineway20230—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K223558CUVIS-spineCurexo, Inc.20230—
+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—
+6K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+6K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+6K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+6K222789VADER® Pedicle System, G21 CementIcotec AG202352
+6K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+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—
+6K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—