510(k) Report

Devices descending from K060290

25 later devices reach Shoulder Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+1K143697Biomet Proximal Humerus Plating SystemBiomet Manufacturing20151718
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K093978Exactech Equinoxe Proximal Humerus Fracture Plate SystemExactech, Inc.20104—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K251620A.L.P.S. Proximal Humerus Plating SystemZimmer Biomet20250—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+2K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K173746Activmotion RangeNewclip Technics20181—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+2K120108Aptus Proximal Humerus SystemMedartis AG20122—
+3K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+3K241539Activmotion SNewclip Technics20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+3K181425APTUS® Proximal Humerus SystemMedartis AG20181—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—