510(k) Report

Devices descending from K153452

15 later devices reach Salto XT, Salto Talaris through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20208—
+1K191380Quantum® Total Ankle ProsthesisIn2bones Sas20200—
+1K182878Integra Salto Total Ankle SystemAscension Orthopedics201818
+1K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC20172—
+2K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20250—
+2K240475Hintermann Series H2 Total Ankle SystemVilex, LLC20240—
+2K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20240—
+2K240591restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc.20240—
+2K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC20230—
+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—
+3K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+3K223227MAVEN™ Patient-Specific InstrumentationParagon 28, Inc.20220—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—