510(k) Report

Devices descending from K023604

19 later devices reach Modification to Radial Head Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S.20131619
+1K060438RHSTornier200618—
+2K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC20172—
+2K153452Salto XT, Salto TalarisTornier S.A.S.2016158
+2K102180Rhead Radial Head Extended StemsSmall Bone Innovations, Inc.201009
+3K240475Hintermann Series H2 Total Ankle SystemVilex, LLC20240—
+3K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC20230—
+3K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20208—
+3K191380Quantum® Total Ankle ProsthesisIn2bones Sas20200—
+3K182878Integra Salto Total Ankle SystemAscension Orthopedics201818
+4K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20250—
+4K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20240—
+4K240591restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc.20240—
+4K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc.20212—
+4K202019Maven Patient-Specific InstrumentationParagon 28, Inc.20211—
+4K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K223227MAVEN™ Patient-Specific InstrumentationParagon 28, Inc.20220—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—