510(k) Report

Devices descending from K990804

106 later devices reach Stayfuse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173616DIP Arthrodesis SystemIn2bones Sas20180—
+1K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+1K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC20140—
+1K130019J-Screw Compression ScrewCompetitive Engineering, Inc.20140—
+1K130859Hammertoe Correction SystemArthrosurface, Inc.20134—
+1K113006I-Fuse Hammer Toe SystemsOrthopro, LLC201227—
+1K110445Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC2011166
+1K022726Stayfuse GT-IPPioneer Surgical Technology200265—
+2K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+2K183228HammerToe Compression SystemParagon 28, Inc.20190—
+2K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc.20170—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+2K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc20149—
+2K133515Peek Fusion ImplantMtp Solutions, LLC20142—
+2K122031Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC20129—
+2K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC200963—
+3K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+3K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+3K172485Footmotion HammerToeNewclip Technics20180—
+3K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+3K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+3K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+3K142478opti-ToeGraham Medical Technologies, LLC (D.B.A.Gramedica)20151—
+3K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc20156—
+3K140970One-Piece Peek Fusion ImplantMtp Solutions, LLC20140—
+3K121417XMCP, Hallux, Tarsx, Extremity Medical Screw SystemExtremity Medical, LLC20122—
+3K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC2010562
+3K093770Extremity Medical Screw SystemExtremity Medical, LLC20103—
+3K091577Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw SystemExtremity Medical, LLC20094—
+4K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+4K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc20210—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+4K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+4K190586Monster® Screw SystemParagon 28, Inc.201921—
+4K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+4K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+4K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+4K142581APTUS Foot SystemMedartis AG201522—
+4K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+4K121349IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and WasherExtremity Medical, LLC201212—
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+5K221342REDEMPTION Beaming SystemVilex, LLC20220—
+5K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K203011Monster Screw SystemParagon 28, Inc.20206—
+5K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+5K191636APTUS Foot SystemMedartis AG20190—
+5K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+5K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+5K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+5K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+5K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+6K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K251555Ultra™ Compression Screw SystemPace Surgical20251—
+6K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+6K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+6K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+6K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+6K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+6K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+6K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+6K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+6K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+7K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+7K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+7K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+7K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+7K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+7K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+7K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+7K192592Axis Plating SystemExtremity Medical, LLC20190—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K260810Anteralign LS coverplateTyber Medical, LLC20260—
+8K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+8K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+8K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—