510(k) Report

Devices descending from K930834

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+5K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+5K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+5K203110iFuse Implant System - iFuse NavigationSI-BONE, Inc.20201—
+5K201538Life Spine SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.202013—
+5K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+5K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+5K183342SambaScrew 3D SI Fusion SystemOrthofix, Inc.201931—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K182983iFuse Implant System®SI-BONE, Inc.201871—
+5K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+5K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+5K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC201611—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K241895Cannulated PsiFGuardSpineguard20240—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+6K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+6K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+6K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+6K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+6K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K231831TiLink-L Joint Fusion SystemSurgentec20232—
+6K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+6K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+6K230689T-FIX™ 3DSI Joint Fusion SystemCutting Edge Spine, LLC20230—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+6K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+6K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+6K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K200696FIREBIRD SI Fusion SystemOrthofix, Inc.2020291
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K190230iFuse Implant System®SI-BONE, Inc.201957—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC20260—
+7K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+7K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+7K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+7K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+7K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+7K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K201664FIREBIRD SI Fusion SystemOrthofix, Inc.202026—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—