510(k) Report

Devices descending from K063875

167 later devices reach Stryker Foot Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K210750Acumed Clavicle Hook Plating SystemAcumed, LLC20210—
+4K201656ARIX Elbow SystemJeil Medical Corporation20200—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+4K180500VariAx 2 SystemStryker GmbH201812—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K171285ARIX Diaphysis SystemJeil Medical Corporation20176—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+5K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+5K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+5K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K210157SOLE Medial Column Fusion PlateOrthofix Srl20210—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K191972ARIX Wrist SystemJeil Medical Corporation20190—
+5K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K172008ARIX Humerus SystemJeil Medical Corporation20173—
+6K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+6K230938ARIX Humerus SystemJeil Medical Corporation20230—
+6K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+6K202912ARIX Ankle Distal Tibia SystemJeil Medical Corporation20201—
+7K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+7K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+7K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+7K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+7K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—