510(k) Report

Devices descending from K955472

28 later devices reach Ace Humerus & Radius Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143697Biomet Proximal Humerus Plating SystemBiomet Manufacturing20151718
+1K061917Distal Radius Locking Plating SystemNewclip Technics20066—
+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—
+2K251620A.L.P.S. Proximal Humerus Plating SystemZimmer Biomet20250—
+2K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+2K223933Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.20230—
+2K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+2K130774Universal Distal Radius SystemNewclip Technics20135—
+3K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+3K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+3K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+3K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+3K173746Activmotion RangeNewclip Technics20181—
+3K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K170843Alians Fragment SpecificNewclip Technics20171—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K213214Xpert WristNewclip Technics20210—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+7K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—