510(k) Report

Devices descending from K100866

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+1K112080Preserve Hip StemWrightmedicaltechnologyinc20118—
+1K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc20114—
+1K111910Gladiator Hip StemWrightmedicaltechnologyinc20115—
+2K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+2K213816MPO Hip InstrumentsMicroport Orthopedics, Inc.20220—
+2K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc.20201—
+2K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—
+2K150133PROFEMUR Preserve Size 1-3 Hip StemsMicroport Orthopedics, Inc.20153—
+2K150302PROFEMUR Preserve Classic StemMicroport Orthopedics, Inc.20154—
+2K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc20120—
+2K121221Profemur Z Revision Hip StemWrightmedicaltechnologyinc20123—
+3K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+3K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—