510(k) Report

Devices descending from K991915

37 later devices reach Modular Radial Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212872Avenger Radial Head SystemIn2bones USA, LLC20210—
+1K192754Avenger Radial Head SystemIn2bones USA, LLC20201—
+1K060731Evolve Modular Radial HeadWrightmedicaltechnologyinc200675
+1K051385Explor Modular Radial Head Replacement DeviceBiomet, Inc.2005212
+1K041858Acumed Anatomic Radial Head SystemAcumed, LLC20042—
+1K040611Modular Radial Head Replacement DeviceBiomet, Inc.2004221
+1K032686Ascension Modular Radial HeadAscension Orthopedics, Inc.20033—
+1K030384Evolve Ceramic Radial Head ImplantWrightmedicaltechnologyinc20030—
+1K012551Liverpool Radial Head Replacement DeviceBiomet, Inc.200223—
+2K260624Arthrex Radial Head Replacement SystemArthrex, Inc.20260—
+2K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+2K183618Revolution Radial HeadIgnite Orthopedics, Inc.201921
+2K132735Axia Radial Head SystemImds (Innovative MEdical Device Systems) - Leis ME20140—
+2K131845Acumed Anatomic Radial Head System, Acumed Anatomic Radial Head Long Stems, Acumed Arh…Acumed, LLC201301
+2K130533Salto Talaris Total Ankle Prosthesis, RHSTornier S.A.S.20131619
+2K112030Synthes Radial Head Prosthesis SystemSynthes USA, LLC201202
+2K102180Rhead Radial Head Extended StemsSmall Bone Innovations, Inc.201009
+2K092721Align Radial Head SystemSkeletal Dynamics, LLC201001
+2K060438RHSTornier200618—
+3K233592BioPoly Radial Head ImplantBioPoly, LLC20240—
+3K213563DePuy Synthes Radial Head Replacement SystemDePuy Synthes20220—
+3K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC20172—
+3K153452Salto XT, Salto TalarisTornier S.A.S.2016158
+4K240475Hintermann Series H2 Total Ankle SystemVilex, LLC20240—
+4K230462OPTIX H2 Patient Specific Instrument SystemVilex, LLC20230—
+4K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20208—
+4K191380Quantum® Total Ankle ProsthesisIn2bones Sas20200—
+4K182878Integra Salto Total Ankle SystemAscension Orthopedics201818
+5K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20250—
+5K240259APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20240—
+5K240591restor3d Kinos Axiom Total Ankle SystemRestor3D, Inc.20240—
+5K210390Apex 3D Total Ankle Replacement SystemParagon 28, Inc.20212—
+5K202019Maven Patient-Specific InstrumentationParagon 28, Inc.20211—
+5K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K223227MAVEN™ Patient-Specific InstrumentationParagon 28, Inc.20220—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—