510(k) Report

Devices descending from K050457

258 later devices reach Merete Metafix Small Fragment Bone Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K151769Anchorage 2 CP SystemStryker GmbH20150—
+6K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+7K262344Large Compression ScrewsTriMed, Inc.20260—
+7K261511Xpert AnkleNewclip Technics20260—
+7K260810Anteralign LS coverplateTyber Medical, LLC20260—
+7K260761APTUS Clavicle System 2.8Medartis AG20260—
+7K261241TriMed Compression ScrewsTriMed, Inc.20260—
+7K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+7K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+7K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+7K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+7K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+7K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+7K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+7K231860TDM Screw SystemTdm Co., Ltd.20240—
+7K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+7K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression…Trax Surgical20230—
+7K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+7K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+7K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+7K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+7K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+7K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—
+7K191009Arsenal Plating SystemTrilliant Surgical20192—
+7K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+8K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+8K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.20260—
+8K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20260—
+8K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+8K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+8K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+8K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+8K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+8K201149CoLink Plating SystemIn2bones USA, LLC20200—
+8K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+8K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+8K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+8K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+9K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+9K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+10K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+10K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+11K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—