510(k) Report

Devices descending from K013442

150 later devices reach Pass Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032094Passmed Spinal SystemMedicrea2003149—
+2K070530Modification to Passmed Spinal SystemMedicrea Technologies20072—
+2K070276Modification to Passmed Spinal SystemMedicrea Technologies20070—
+2K062136Pass 2 Spinal SystemMedicrea2006146—
+3K190376PASS LP Spinal SystemMedicrea International SA201915
+3K121979Pass Oct Spinal SystemMedicrea International201314—
+3K112493Pass LP Spinal SystemMedicrea International20111—
+3K110497Pass LP Spinal SystemMedicrea International20111331
+4K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+4K153413PASS LP Spinal SystemMedicrea International SA20160—
+4K150918PASS OCT Spinal SystemMedicrea International SA201513—
+4K123138Pass LP Spinal SystemMedicrea International2013132—
+5K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+5K161149PASS OCT Spinal SystemMedicrea International SA20160—
+5K160756PASS OCT Spinal SystemMedicrea International SA20160—
+5K153169PASS OCT Patient Specific RodsMedicrea International20164—
+5K142798PASS LP Spinal SystemMedicrea International SA201584—
+5K150049PASS LP Spinal SystemMedicrea International20150—
+5K141398Pass LP Spinal SystemMedicrea International SA2015101
+5K140738Pass LP Spinal SystemMedicrea International201447—
+5K132574Pass LP Spinal SystemMedicrea International20130—
+5K132575Pass LP Spinal SystemMedicrea International20130—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K211981KHEIRON® Spinal Fixation SystemS.M.A.I.O20228—
+6K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+6K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+6K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+6K202771CD Horizon Spinal SystemMedtronic202021—
+6K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+6K180376K2M Patient Specific RodsK2m, Inc.20182—
+6K160640PASS XS Spinal SystemMedicrea International SA20160—
+6K161627PASS LP Spinal SystemMedicrea International SA20167—
+6K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+7K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+7K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+7K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K211323ASTRA Spine SystemSpinecraft, LLC202112—
+7K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+7K210306GII Spinal Fixation SystemColigne AG20210—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+7K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+7K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+7K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+7K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+7K162786PASS LP Spinal SystemMedicrea International SA20176—
+7K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+8K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+8K253545Vulcan Spinal SystemK2m, Inc.20260—
+8K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+8K182240PASS LP Spinal SystemMedicrea International SA20182—
+8K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+8K180324Patriot Spinal Fixation SystemValorus Spine20180—
+8K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+8K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+8K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+9K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+9K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+9K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+9K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+9K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+9K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—