510(k) Report

Devices descending from K041167

197 later devices reach Pioneer Surgical Technology Quantum Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+8K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+8K211323ASTRA Spine SystemSpinecraft, LLC202112—
+8K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+8K210306GII Spinal Fixation SystemColigne AG20210—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+8K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+8K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+8K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+8K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+8K162786PASS LP Spinal SystemMedicrea International SA20176—
+8K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K253545Vulcan Spinal SystemK2m, Inc.20260—
+9K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K223273ASTRA Spine SystemSpinecraft, LLC20228—
+9K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+9K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+9K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+9K182240PASS LP Spinal SystemMedicrea International SA20182—
+9K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+9K180324Patriot Spinal Fixation SystemValorus Spine20180—
+9K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+9K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+9K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+10K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+10K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+10K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+10K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+10K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+10K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+10K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+10K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+10K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+10K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+10K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+10K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+10K190376PASS LP Spinal SystemMedicrea International SA201915
+11K252322SIros-X SystemGenesys Spine20250—
+11K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+11K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+11K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+11K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+11K232432E3D™-A Interbody SystemEvolution Spine20248—
+11K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+11K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+11K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+11K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+11K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+11K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+12K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+12K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+12K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+12K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+12K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+12K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+12K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+12K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+12K241846E3D™-C Interbody SystemEvolution Spine20246—
+12K240368E3D™-A Interbody SystemEvolution Spine20247—
+12K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+12K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+12K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+12K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+12K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+12K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+13K262094E3D™-C Interbody SystemEvolution Spine20260—
+13K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+13K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+13K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+13K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+13K260038E3D™-C Interbody SystemEvolution Spine20261—
+13K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+13K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+13K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+13K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+13K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+13K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+13K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+13K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+14K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—