510(k) Report

Devices descending from K060026

103 later devices reach Koby Surgical Internal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemAscension Orthopedics20171—
+1K160304OsteoBullet Compression ScrewPhalanx Innovations20168—
+1K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.2012391
+1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+2K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev420250—
+2K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—
+2K240212COGNiTiON™ Staple SystemOrtho Solutions UK, Ltd.20240—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K200291CREED™ Cannulated ScrewsGlw Medical, Inc.20202—
+2K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH20190—
+2K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+2K172973Life Spine Foot and Ankle Plating SystemLife Spine, Inc.20170—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+2K151407RECON systemNormed Medizin-Technik GmbH20154—
+2K142057Infix Cannulated Screw SystemInfix Medical, LLC20151—
+2K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+2K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH2013242
+2K123890Acumed Cannulated Screw SystemAcumed, LLC2013362
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K223847CREED™ Cannulated ScrewsGlw, Inc.20230—
+3K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC202204
+3K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+3K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+3K191995S4 Screw SystemSubchondral Solutions, Inc.20202—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+3K190830TDM Screw SystemsTdm Co., Ltd.20191—
+3K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K162171S4 Screw System™Subchondral Solutions20173—
+3K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+3K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+3K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K231860TDM Screw SystemTdm Co., Ltd.20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K220901S-Core Implant SystemSubchondral Solutions, Inc.20220—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K201430InFrame™ Cannulated Fixation SystemExsomed Corp.20201—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+5K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.20220—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—