510(k) Report

Devices descending from K101700

56 later devices reach IO Fix Hand, IO Fix Foot, Extremity Medical Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+1K190586Monster® Screw SystemParagon 28, Inc.201921—
+1K142581APTUS Foot SystemMedartis AG201522—
+1K121349IO Fix, IO Fix Plus, Carpalfix, Extremity Medical Screw and WasherExtremity Medical, LLC201212—
+2K221342REDEMPTION Beaming SystemVilex, LLC20220—
+2K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+2K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+2K203011Monster Screw SystemParagon 28, Inc.20206—
+2K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC20201—
+2K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+2K192578InCore TMT SystemNextremity Solutions, Inc.20191—
+2K191636APTUS Foot SystemMedartis AG20190—
+2K180257InCore® Lapidus SystemNextremity Solutions, Inc.20183—
+2K172260Omni Foot Plating SystemExtremity Medical, LLC20174—
+2K162674BioPro Foot Plating SystemsBiopro, Inc.201719—
+2K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+2K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+3K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+3K251555Ultra™ Compression Screw SystemPace Surgical20251—
+3K251892MAXXOS P.A.C.E. Foot & Ankle Plating SystemMaxxos Medical GmbH20250—
+3K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+3K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+3K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+3K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+3K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+3K200124InCore MPJ SystemNextremity Solutions, Inc.20200—
+3K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+3K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.20190—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+3K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K221362Omni Foot and Ankle Plating SystemExremity Medical, LLC20220—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—