510(k) Report

Devices descending from K081071

80 later devices reach Synthes 6.5MM Midfoot Fusion Bolt through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193366T2 ICFStryker GmbH20201—
+1K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+1K182677DynaNail MiniMedShape, Inc.20195—
+1K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+1K082934Extremity Medical Midfoot Screw SystemExtremity Medical, LLC200963—
+2K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+2K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+2K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+2K202326BESPA Charcot SystemBespa Global, LLC20210—
+2K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+2K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+2K203381Dynanail Mini HybridMedShape, Inc.202141
+2K180024SALVATION Midfoot NailWrightmedicaltechnologyinc20182—
+2K172698G-Beam Fusion Beaming SystemOrthofix Srl20180—
+2K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+2K121417XMCP, Hallux, Tarsx, Extremity Medical Screw SystemExtremity Medical, LLC20122—
+2K101700IO Fix Hand, IO Fix Foot, Extremity Medical Screw SystemExtremity Medical, LLC2010562
+2K093770Extremity Medical Screw SystemExtremity Medical, LLC20103—
+2K091577Extremity Medical Midfoot Screw System, Charcx, Intramedullary Screw SystemExtremity Medical, LLC20094—
+3K240530DynaNail Mini Tapered HybridMedShape, Inc.20242—
+3K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+3K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+3K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbH20220—
+3K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+3K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+3K190586Monster® Screw SystemParagon 28, Inc.201921—
+3K142581APTUS Foot SystemMedartis AG201522—
+3K130120Extremity Medical IP Fusion SystemExtremity Medical, LLC20130—
+3K121349IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and WasherExtremity Medical, LLC201212—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K203011Monster Screw SystemParagon 28, Inc.20206—
+4K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+4K191636APTUS Foot SystemMedartis AG20190—
+4K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+4K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+4K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+4K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K251555Ultra™ Compression Screw SystemPace Surgical20251—
+5K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+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—
+5K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+5K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+5K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+5K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+5K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+6K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+6K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+6K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+6K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+6K192592Axis Plating SystemExtremity Medical, LLC20190—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—