510(k) Report

Devices descending from K944507

28 later devices reach Metallic Radial Head Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K001385Howmedica Osteonics Radial Head ProthesisHowmedica Osteonics Corp.20000—
+1K992220Radial Head ProsthesisSmith & Nephew, Inc.20001—
+1K982288Radial Head ImplantAvanta Orthopaedics, Inc.1998271
+2K192754Avenger Radial Head SystemIn2bones USA, LLC20201—
+2K032686Ascension Modular Radial HeadAscension Orthopedics, Inc.20033—
+2K023604Modification to Radial Head ImplantAvanta Orthopaedics, Inc.20021918
+3K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+3K212872Avenger Radial Head SystemIn2bones USA, LLC20210—
+3K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S.20131619
+3K112030Synthes Radial Head Prosthesis SystemSynthes USA, LLC201202
+3K102180Rhead Radial Head Extended StemsSmall Bone Innovations, Inc.201009
+3K060438RHSTornier200618—
+4K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC20172—
+4K153452Salto XT, Salto TalarisTornier S.A.S.2016158
+5K240475Hintermann Series H2 Total Ankle SystemVilex, LLC20240—
+5K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC20230—
+5K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20208—
+5K191380Quantum® Total Ankle ProsthesisIn2bones Sas20200—
+5K182878Integra Salto Total Ankle SystemAscension Orthopedics201818
+6K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20250—
+6K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20240—
+6K240591restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc.20240—
+6K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc.20212—
+6K202019Maven Patient-Specific InstrumentationParagon 28, Inc.20211—
+6K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+7K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K223227MAVEN™ Patient-Specific InstrumentationParagon 28, Inc.20220—
+8K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—