510(k) Report

Devices descending from K030310

151 later devices reach Synthes Stainless Steel Modular Hand System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K262344Large Compression ScrewsTriMed, Inc.20260—
+4K261241TriMed Compression ScrewsTriMed, Inc.20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+4K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+4K231860TDM Screw SystemTdm Co., Ltd.20240—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+4K213214Xpert WristNewclip Technics20210—
+4K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K173641Activ AnkleNewclip Technics20183—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+4K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+5K261511Xpert AnkleNewclip Technics20260—
+5K261191Alians Elbow SNewclip Technics20260—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K191009Arsenal Plating SystemTrilliant Surgical20192—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+6K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+6K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+6K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+7K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+7K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+8K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+8K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+9K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—