510(k) Report

Devices descending from K020152

1,684 later devices reach Synthes Vertebral Spacer TI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+12K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+12K223430ProLift Micro Expandable Spacer SystemLife Spine, Inc.20236—
+12K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+12K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+12K213815SiJoin®T3Vgi Medical, Inc.20230—
+12K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+12K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+12K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+12K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+12K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+12K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+12K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+12K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+12K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+12K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+12K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+12K182349Concorde LiftMedos International SARL20190—
+12K181014Tritanium PL CageStryker Spine2018137—
+12K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+12K173537Concorde Lift™Medos International SARL20181—
+12K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+12K171519FLXfit™Expanding Orthopedics, Inc.2017711
+12K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+12K141217Acculif TL and PL CageStryker Corporation20146423
+13K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+13K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+13K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+13K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+13K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+13K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+13K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+13K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+13K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+13K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+13K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+13K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+13K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+13K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+13K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+13K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+13K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+13K230989Rod Registration FrameNu Vasive, Incorporated20230—
+13K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+13K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+13K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+13K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+13K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+13K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+13K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+13K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+13K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+14K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+14K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+14K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+14K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+14K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+14K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+14K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+14K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+14K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+14K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+14K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+14K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+14K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+14K191575ARx Spinal SystemLife Spine, Inc.201910—
+15K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+15K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+15K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+15K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+15K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+15K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+15K220025ARx® Spinal SystemLife Spine, Inc.20220—
+15K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+15K200070ARx Spinal SystemLife Spine, Inc.20209—
+16K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+16K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+16K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+16K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+16K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+16K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+16K210549ARx Spinal SystemLife Spine, Inc.20211—
+16K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+17K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—