510(k) Report

Devices descending from K930834

219 later devices reach Acutract through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242973CanMINI Hand and Foot SystemCanwell Medical Co., Ltd.20250—
+1K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+1K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+1K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc.20051452
+1K030706Ebi Dynafix Compression Bone ScrewEbi, L.P.200369—
+2K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+2K080398SI Joint Fusion SystemSI-BONE, Inc.2008144—
+3K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+3K160652iFUSE Implant SystemSI-BONE, Inc.201683—
+3K160058Biomet Variable Pitch Compression Screw SystemBiomet, Inc.20160—
+3K151718iFuse Implant SystemSI-BONE, Inc.201585—
+3K150875iFuse Implant SystemSI-BONE, Inc.201586—
+3K150126Life Spine Cannulated ScrewsLife Spine, Inc.20153—
+3K150714SI-BONE iFuse Implant SystemSI-BONE, Inc.201586—
+3K141049Ifuse Implant SystemSI-BONE, Inc.201488—
+3K131405Ifuse Implant SystemSI-BONE, Inc.2013133—
+3K131061Restore Bunion Correction SystemNextremity Solutions201315—
+3K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+3K123850Ifuse Implant SystemSI-BONE, Inc.2013134—
+3K122074Ifuse Implant SystemSI-BONE, Inc.2012139—
+3K110472SI-Fix Sacroiliac Joint Fusion SystemMedtronic Sofamor Danek201292—
+3K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+3K110838Ifuse Implant SystemSI-BONE, Inc.2011143—
+4K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+4K252322SIros-X SystemGenesys Spine20250—
+4K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+4K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+4K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+4K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+4K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+4K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+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—
+4K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+4K172268iFuse Implant System- iFuse NavigationSI-BONE, Inc.201746—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K162733iFuse Implant System® - iFuse-3D implantSI-BONE, Inc.201782—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K161755Integrity-SI TM Fusion SystemCoorstek Medical20162—
+4K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+4K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+4K152681iFuse Implant System (R)SI-BONE, Inc.201684—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K151407RECON systemNormed Medizin-Technik GmbH20154—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K150017SpineFrontier SIJFuse Sacroiliac Joint Fusion Device SystemSpinefrontier, Inc.201514—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+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—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+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—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+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—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+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—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+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—
+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—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+5K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—