510(k) Report

Devices descending from K003043

1,819 later devices reach Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+11K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+11K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+11K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+11K221244CD Horizon™ Spinal SystemMedtronic202220—
+11K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+11K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+11K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+11K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+11K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+11K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+11K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+11K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+11K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+11K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+11K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+11K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+11K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+11K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+11K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+11K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+11K172115Navigated Instrument SystemOrthofix, Inc.20184—
+11K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+11K162921Navigated Instrument SystemOrthofix, Inc.20175—
+11K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+12K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+12K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+12K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+12K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+12K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+12K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+12K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+12K241895Cannulated PsiFGuardSpineguard20240—
+12K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+12K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+12K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+12K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+12K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+12K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+12K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+12K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+12K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+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—
+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—
+12K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+12K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+12K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+12K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+12K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+12K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+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—
+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