510(k) Report

Devices descending from K140454

396 later devices reach Navigated CD Horizon Solera Screwdriver/Taps through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+4K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200896Solstice CCILife Spine, Inc.20200—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+5K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+5K251943Spineology Navigation InstrumentsSpineology, Inc.20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+5K243693NEO Pedicle Screw System™Neo Medical SA20240—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+5K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+5K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K241130“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)Point Robotics MedTech, Inc.20242—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+5K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+5K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+5K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252755POINT Kinguide Agile Robotic Arm Surgical Stereotactic SystemPoint Robotics MedTech, Inc.20260—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+6K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+6K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+6K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K240368E3D™-A Interbody SystemEvolution Spine20247—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+6K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+7K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+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—
+7K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—