510(k) Report

Devices descending from K103049

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+6K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+6K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+6K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+6K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+6K223273ASTRA Spine SystemSpinecraft, LLC20228—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+6K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+6K180324Patriot Spinal Fixation SystemValorus Spine20180—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+6K172194Connector SystemOrthofix, Inc.2017162
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K151216Everest Spinal SystemK2m, Inc.201511—
+7K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+7K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+7K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+7K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+7K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+7K190751Connector SystemOrthofix, Inc.20193—
+7K190376PASS LP Spinal SystemMedicrea International SA201915
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K220025ARx® Spinal SystemLife Spine, Inc.20220—