510(k) Report

Devices descending from K091423

36 later devices reach Profemur Hip System Modular Necks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+1K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+1K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+1K112080Preserve Hip StemWrightmedicaltechnologyinc20118—
+1K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc20114—
+1K111910Gladiator Hip StemWrightmedicaltechnologyinc20115—
+1K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+1K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc201014Class I
+2K243809Biolox® Delta Revision headsLimacorporate20250—
+2K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+2K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+2K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc.20201—
+2K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+2K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K150133PROFEMUR Preserve Size 1-3 Hip StemsMicroport Orthopedics, Inc.20153—
+2K150302PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc.20154—
+2K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+2K141327Minima S SystemLima Corporate S.P.A.20145—
+2K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+2K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc20120—
+2K121684Novation Lpi Prime Femoral StemExactech, Inc.20121—
+2K121221Profemur Z Revision Hip StemWrightmedicaltechnologyinc20123—
+2K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+3K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+3K231925MINIMA S SystemLima Corporate S.P.A.20230—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+3K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+3K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K261576Icona Hip StemCorin, Ltd.20260—