510(k) Report

Devices descending from K944330

172 later devices reach Acutrak Plus Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230—
+1K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+1K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171—
+1K170594I.B.S. osteosynthesis screwsIn2bones Sas20171—
+1K131920Stabilization ScrewIn2bones Sas2014183
+1K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc.20051452
+1K040265Little Grafter ScrewBiocomposites, Ltd.20041—
+1K972722Ultimate Compression Screw SystemOrthopedic Designs, Inc.19980—
+2K254280F.A.S.T ScrewSteps Ortho20260—
+2K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+2K210159IntraLock SystemFusion Orthopedics, LLC20210—
+2K170518In2Bones Fracture and Correction SystemIn2bones USA, LLC2017151
+2K160174I.B.S. 2.0 Osteosynthesis screwIn2bones Sas201617—
+2K080398SI Joint Fusion SystemSI-BONE, Inc.2008144—
+2K073312Osteotrans-OT ScrewTakiron Co., Ltd.20080—
+3K201149CoLink Plating SystemIn2bones USA, LLC20200—
+3K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+3K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+3K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+3K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+3K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+3K160652iFUSE Implant SystemSI-BONE, Inc.201683—
+3K151718iFuse Implant SystemSI-BONE, Inc.201585—
+3K150875iFuse Implant SystemSI-BONE, Inc.201586—
+3K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.201586—
+3K141049Ifuse Implant SystemSI-BONE, Inc.201488—
+3K131405Ifuse Implant SystemSI-BONE, Inc.2013133—
+3K123850Ifuse Implant SystemSI-BONE, Inc.2013134—
+3K122074Ifuse Implant SystemSI-BONE, Inc.2012139—
+3K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292—
+3K110838Ifuse Implant SystemSI-BONE, Inc.2011143—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+4K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+4K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+4K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+4K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K193524SI-BONE iFuse Implant System®SI-BONE, Inc.202054—
+4K181881Outlet Sacroiliac Joint Fusion SystemSij Surgical20184—
+4K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+4K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+4K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+4K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+4K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+4K152681iFuse Implant System (R)SI-BONE, Inc.201684—
+4K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSpinefrontier, Inc.201514—
+4K140079Silex Sacroiliac Joint Fusion SystemX-Spine Systems, Inc.201412—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+5K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+5K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+5K253611Falco Fusion SystemMcnicoll Surgical, Inc.20260—
+5K251365OptumSI Implant SystemSi Solutions, LLC20250—
+5K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+5K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+5K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+5K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+5K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+5K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+5K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+5K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+5K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+5K230817TORPEDO Implant System®Deltacor GmbH20240—
+5K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+5K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+5K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+5K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+5K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+5K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC20233—
+5K213815SiJoin®T3Vgi Medical, Inc.20230—
+5K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+5K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+5K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+5K222512Integrity-SI Fusion SystemOsteoCentric Technologies20221—
+5K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+5K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+5K214123T-FIX® 3DSI Joint Fusion SystemCutting Edge Spine, LLC20221—
+5K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+5K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+5K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+5K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—