510(k) Report

Devices descending from K171067

13 later devices reach INVISION Total Ankle Revision System through their predicates, nearest generation first.

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