510(k) Report

Devices descending from K022271

180 later devices reach Plus Pivot Link Universal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+11K253545Vulcan Spinal SystemK2m, Inc.20260—
+11K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+11K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+11K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+11K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+11K223273ASTRA Spine SystemSpinecraft, LLC20228—
+11K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+11K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+11K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+11K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+11K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+11K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+11K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+11K182240PASS LP Spinal SystemMedicrea International SA20182—
+11K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+11K180324Patriot Spinal Fixation SystemValorus Spine20180—
+11K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+11K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+11K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+12K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+12K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+12K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+12K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+12K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+12K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+12K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+12K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+12K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+12K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+12K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+12K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+12K190376PASS LP Spinal SystemMedicrea International SA201915
+13K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+13K252322SIros-X SystemGenesys Spine20250—
+13K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+13K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+13K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+13K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+13K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+13K232432E3D™-A Interbody SystemEvolution Spine20248—
+13K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+13K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+13K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+13K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+13K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+13K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+13K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+14K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+14K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+14K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+14K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+14K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+14K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+14K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+14K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+14K241846E3D™-C Interbody SystemEvolution Spine20246—
+14K240368E3D™-A Interbody SystemEvolution Spine20247—
+14K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+14K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+14K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+14K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+14K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+14K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+15K262094E3D™-C Interbody SystemEvolution Spine20260—
+15K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+15K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+15K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+15K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+15K260038E3D™-C Interbody SystemEvolution Spine20261—
+15K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+15K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+15K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+15K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+15K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+15K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+15K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+15K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+16K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—