510(k) Report

Devices descending from K962984

587 later devices reach Isola Pediatric Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+7K161627PASS LP Spinal SystemMedicrea International SA20167—
+7K153413PASS LP Spinal SystemMedicrea International SA20160—
+7K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+7K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583—
+7K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K253250Minuteman® G6 MIS Fusion PlateSpinal Simplicity, LLC20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+8K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+8K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+8K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+8K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K210306GII Spinal Fixation SystemColigne AG20210—
+8K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+8K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+8K182182YUKON OCT Spinal SystemK2m20185—
+8K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+8K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+8K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+8K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+8K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+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—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+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—
+9K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+9K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K200896Solstice CCILife Spine, Inc.20200—
+9K193129Yukon OCT Spinal SystemK2m, Inc.202001
+9K183381Navigation Enabled InstrumentsStryker20191—
+9K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+9K180324Patriot Spinal Fixation SystemValorus Spine20180—
+10K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—