510(k) Report

Devices descending from K133974

20 later devices reach Variax Distal Radius Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+2K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+2K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+2K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+2K173746Activmotion RangeNewclip Technics20181—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+3K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+3K241539Activmotion SNewclip Technics20240—
+3K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+3K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+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—