510(k) Report

Devices descending from K010720

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K142360Everest Spinal SystemK2m, Inc.201522—
+7K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+7K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+7K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+7K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+7K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+7K223273ASTRA Spine SystemSpinecraft, LLC20228—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+7K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+7K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+7K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+7K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+7K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+7K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+7K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+7K182240PASS LP Spinal SystemMedicrea International SA20182—
+7K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+7K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+7K180324Patriot Spinal Fixation SystemValorus Spine20180—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+7K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+8K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+8K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+8K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+8K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+8K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+8K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+8K190751Connector SystemOrthofix, Inc.20193—
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K252322SIros-X SystemGenesys Spine20250—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—