510(k) Report

Devices descending from K093058

478 later devices reach TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+5K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+5K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K233256Robotic Integration InstrumentsDePuy Synthes20240—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+5K210306GII Spinal Fixation SystemColigne AG20210—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+5K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+5K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+5K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+5K182182YUKON OCT Spinal SystemK2m20185—
+5K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+5K182240PASS LP Spinal SystemMedicrea International SA20182—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+5K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K171321K2M Navigation InstrumentsK2m201711
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K170647Connector SystemOrthofix, Inc.201718—
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+5K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+5K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+5K151977icotec Pedicle SystemIcotec AG201630—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+5K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+6K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—