510(k) Report

Devices descending from K082072

36 later devices reach Synthes (Usa) 3.5MM LCP Hook Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243469SignexOsteonic Co., Ltd.20250—
+1K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes20244—
+1K223118OIC Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20231—
+1K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC20191—
+1K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+1K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc.20161—
+1K143394Acumed Small Fragment Base SetAcumed, LLC201518—
+2K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+2K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+2K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+2K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+2K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+2K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+2K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+2K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+2K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+2K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+2K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+2K162898Olecranon Plating SystemMiami Device Solutions, LLC20171—
+2K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—