510(k) Report

Devices descending from K081513

256 later devices reach Merete 3.0 and 3.5 MM Locking Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K262344Large Compression ScrewsTriMed, Inc.20260—
+6K261511Xpert AnkleNewclip Technics20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K260761APTUS Clavicle System 2.8Medartis AG20260—
+6K261241TriMed Compression ScrewsTriMed, Inc.20260—
+6K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+6K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+6K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+6K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+6K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+6K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K231860TDM Screw SystemTdm Co., Ltd.20240—
+6K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+6K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+6K233017TM Plating SystemTyber Medical, LLC20231—
+6K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+6K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+6K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+6K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+6K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+6K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+6K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+6K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+6K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+6K191009Arsenal Plating SystemTrilliant Surgical20192—
+6K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+7K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+7K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+7K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+7K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+7K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+7K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+7K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+7K201149CoLink Plating SystemIn2bones USA, LLC20200—
+7K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+7K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+7K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+7K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+8K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+8K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+9K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+9K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+9K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—