510(k) Report

Devices descending from K042059

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093978Exactech Equinoxe Proximal Humerus Fracture Plate SystemExactech, Inc.20104—
+1K051728Modification to Shoulder Fixation SystemHand Innovations, LLC200530—
+1K051412Humeral Head Plate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH200521
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+2K120108Aptus Proximal Humerus SystemMedartis AG20122—
+2K063095Humerus Locking Plating SystemNewclip Technics20064—
+2K060290Shoulder Fixation SystemHand Innovations, LLC200625—
+2K052294Shoulder Nail PlateHand Innovations, LLC20050—
+3K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+3K181425APTUS® Proximal Humerus SystemMedartis AG20181—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K143697Biomet Proximal Humerus Plating SystemBiomet Manufacturing20151718
+3K141548High Tibial Osteotomy SystemNewclip Technics20153—
+3K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K251620A.L.P.S. Proximal Humerus Plating SystemZimmer Biomet20250—
+4K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+4K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+4K213214Xpert WristNewclip Technics20210—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K173746Activmotion RangeNewclip Technics20181—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+7K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+7K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—