510(k) Report

Devices descending from K010783

484 later devices reach 2.0/2.4 Cannulated Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+5K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+5K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+5K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+5K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+5K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+5K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+5K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+5K254182AsterOsteonic Co., Ltd.20260—
+5K254162KLS Martin Ixos SystemKLS Martin L.P.20260—
+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—
+5K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+5K251365OptumSI Implant SystemSi Solutions, LLC20250—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.20250—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+5K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+5K250251Eleganz Fusion Screw System (Fusion Screw System)Dev420250—
+5K243469SignexOsteonic Co., Ltd.20250—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+5K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+5K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+5K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+5K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+5K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+5K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+5K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+5K230817TORPEDO Implant System®Deltacor GmbH20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc.20232—
+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—
+5K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc.20231—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+5K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+5K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+5K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC20233—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K213815SiJoin®T3Vgi Medical, Inc.20230—
+5K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+5K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+5K221090Metal Cannulated ScrewDouble Medical Technology, Inc.20230—
+5K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+5K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+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—
+5K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+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—
+5K220244DVR® Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech20220—
+5K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K213590Blue Topaz Sacroiliac Screw SystemOsseus Fusion Systems, LLC20221—
+5K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+5K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+5K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+5K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+5K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+5K203834Arthrex Patella SuturePlatesArthrex, Inc.20211—
+5K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+5K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+5K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—