510(k) Report

Devices descending from K130533

16 later devices reach Salto Talaris Total Ankle Prosthesis, RHS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC20172—
+1K153452Salto XT, Salto TalarisTornier S.A.S.2016158
+2K240475Hintermann Series H2 Total Ankle SystemVilex, LLC20240—
+2K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC20230—
+2K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20208—
+2K191380Quantum® Total Ankle ProsthesisIn2bones Sas20200—
+2K182878Integra Salto Total Ankle SystemAscension Orthopedics201818
+3K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20250—
+3K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20240—
+3K240591restor3d Kinos Axiom Total Ankle SystemRestor3D, 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—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K223227MAVEN™ Patient-Specific InstrumentationParagon 28, Inc.20220—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—