510(k) Report

Devices descending from K033805

142 later devices reach Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K180972ARIX Clavicle SystemJeil Medical Corporation20181—
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+4K173746Activmotion RangeNewclip Technics20181—
+4K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+4K093868I.T.S. LRS Locking Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH201011
+4K082078Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna PlatesZimmer, Inc.200847
+5K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K250988KLS Martin Pure Pectus SystemKLS-Martin L.P.20250—
+5K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+5K240318SITTER 3.5mm Versatile SystemBonebridge AG20244—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+5K201149CoLink Plating SystemIn2bones USA, LLC20200—
+5K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—
+5K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+5K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+5K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+5K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+5K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+5K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+6K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+6K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc.20200—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—