510(k) Report

Devices descending from K123059

21 later devices reach Inbone ( I and II) Total Ankle Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+1K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC20172—
+1K141740Infinity (TM) Total Ankle System; Inbone Total Ankle SystemWrightmedicaltechnologyinc201517—
+2K240475Hintermann Series H2 Total Ankle SystemVilex, LLC20240—
+2K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC20230—
+2K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+2K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+2K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc201713—
+3K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20208—
+3K180730INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc20183—
+4K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20250—
+4K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20240—
+4K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc.20212—
+4K202019Maven Patient-Specific InstrumentationParagon 28, Inc.20211—
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+4K193067The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total…Wrightmedicaltechnologyinc20202—
+5K250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)20251—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K223227MAVEN™ Patient-Specific InstrumentationParagon 28, Inc.20220—
+6K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)20260—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—