510(k) Report

Devices descending from K040928

1,504 later devices reach Expandable Peek VBR Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+9K151216Everest Spinal SystemK2m, Inc.201511—
+9K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+9K133402K2M Modular HooksK2m, Inc.20140—
+9K141217Acculif TL and PL CageStryker Corporation20146423
+10K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+10K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+10K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+10K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+10K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+10K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+10K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+10K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+10K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+10K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+10K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+10K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+10K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+10K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+10K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+10K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+10K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+10K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+10K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+10K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+10K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+10K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+10K190885Elevation Spine Saber-C SystemElevation Spine201925—
+10K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+10K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+10K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+10K181014Tritanium PL CageStryker Spine2018137—
+10K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+10K181188EVEREST Spinal SystemK2m, Inc.20186—
+10K171321K2M Navigation InstrumentsK2m201711
+10K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+10K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+10K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+10K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+11K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+11K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+11K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+11K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+11K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+11K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+11K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+11K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+11K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+11K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+11K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+11K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+11K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+11K211903Shoreline Threaded TruProfile® PlateSeaSpine Orthopedics Corporation20217—
+11K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+11K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+11K201006K2M Navigation InstrumentsK2m, Inc.20200—
+11K191575ARx Spinal SystemLife Spine, Inc.201910—
+11K171425Concorde LiftMedos International SARL201782
+12K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+12K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+12K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+12K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+12K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+12K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+12K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+12K220025ARx® Spinal SystemLife Spine, Inc.20220—
+12K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+12K200070ARx Spinal SystemLife Spine, Inc.20209—
+12K182349Concorde LiftMedos International SARL20190—
+12K173537Concorde Lift™Medos International SARL20181—
+13K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+13K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+13K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+13K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+13K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+13K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—