510(k) Report

Devices descending from K141740

17 later devices reach Infinity (TM) Total Ankle System; Inbone Total Ankle System through their predicates, nearest generation first.

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