510(k) Report

Devices descending from K111620

26 later devices reach Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182492Geminus Volar Distal Radius Plate SystemSkeletal Dynamics, LLC20186—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+1K122310Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20130—
+1K122737Geminus Fossa Specific Plate SystemSkeletal Dynamics, LLC20123—
+2K252949Geminus Volar Distal Radius Plating SystemSkeletal Dynamics, Inc.20250—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+2K213214Xpert WristNewclip Technics20210—
+2K202971DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20212—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K200538Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc.20201—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K173746Activmotion RangeNewclip Technics20181—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K242055Freefix Forearm Plating SystemSkeletal Dynamics, Inc.20240—
+3K241539Activmotion SNewclip Technics20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K233531OIC FLEX-FIX™ SystemOrthopaedic Implant Company20240—
+3K212601DRPx Locking Distal Radius Plate SystemOrthopaedic Implant Company20220—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+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—