510(k) Report

Devices descending from K043206

1,571 later devices reach Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+9K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+9K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+9K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+9K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+9K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+9K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+9K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+9K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+9K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+9K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+9K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+9K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+9K230989Rod Registration FrameNu Vasive, Incorporated20230—
+9K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+9K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+9K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+9K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+9K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+9K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+9K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+9K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+9K182349Concorde LiftMedos International SARL20190—
+9K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+9K181014Tritanium PL CageStryker Spine2018137—
+9K173537Concorde Lift™Medos International SARL20181—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+10K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+10K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+10K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+10K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+10K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+10K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+10K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+10K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+10K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+10K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+10K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+10K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+10K191575ARx Spinal SystemLife Spine, Inc.201910—
+11K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+11K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+11K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+11K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+11K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+11K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+11K220025ARx® Spinal SystemLife Spine, Inc.20220—
+11K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+11K200070ARx Spinal SystemLife Spine, Inc.20209—
+12K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+12K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+12K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+12K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+12K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+12K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+12K210549ARx Spinal SystemLife Spine, Inc.20211—
+12K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+13K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—