510(k) Report

Devices descending from K192994

8 later devices reach Paragon 28 APEX 3D Total Ankle Replacement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20250—
+1K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20240—
+1K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc.20212—
+1K202019Maven Patient-Specific InstrumentationParagon 28, Inc.20211—
+1K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+2K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+2K223227MAVEN™ Patient-Specific InstrumentationParagon 28, Inc.20220—
+3K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—